Data / Medical devices / United States / Integra LifeSciences Corporation
Integra LifeSciences Corporation: FDA-registered device maker in Princeton, NJ, United States, 317 510(k) clearances and 5 PMA approvals
Integra LifeSciences Corporation is registered with the FDA (registration 3003418325) in Princeton, NJ, United States. It lists 429 device types. The FDA files 317 510(k) clearances and 5 PMA approvals under its listings, the newest dated June 23, 2026. 124 recall events name it as the recalling firm (7 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003418325
- Address
- 1100 Campus Road, Princeton, NJ, United States, 08540
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Complaint file establishment, Manufacturer for export, Specification developer
- First device listed
- February 24, 1981
- Registered through
- 2026
- Brand names listed
- 225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710, 33-31;33-31A;33-31AA;33-31AA-P/25;33-31A-P/25;33-31B;33-31-P/25;33-32;33-32-P/25;33-33;33-33-SH;33-34;33-34-P/25, 33-34-SH;33-35;33-35-SH;33-36;33-36-SH;33-37;33-38, 33-52;33-53;33-54;33-55;33-57, 4-110;4-111;4-112;4-112B;4-115;4-115C;4-120;4-121;4-122;4-123;4-125;4-310;4-311;4-312;4-312B;4-315;4-315C;4-320;4-321, 4-322;4-323;4-325;4610;4611;4615, 5-700;5-702;5801;5803;5804, 5-800 and more
Devices it lists
29 more device types in the FDA listing
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 317.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 2026 | K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| April 9, 2025 | K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | GWG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| July 11, 2024 | K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | KGN | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| July 11, 2024 | K241706 | MicroMatrix® UBM Particulate | KGN | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| March 22, 2024 | K233578 | BAHADIR STERILIZATION CONTAINERS | KCT | Substantially Equivalent | Bahadir USA, LLC | accessdata.fda.gov |
| February 4, 2024 | K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | GWM | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| January 17, 2024 | K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| December 19, 2023 | K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| October 27, 2023 | K232618 | Aurora Surgiscope System | GWG | Substantially Equivalent | Rebound Therapeutics Corporation | accessdata.fda.gov |
| September 22, 2023 | K230980 | MicroMatrix® Flex | KGN | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| July 21, 2023 | K231862 | TruDi® Navigation System V3 (FG-2000-00) | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| July 11, 2023 | K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| February 1, 2023 | K223330 | Certas Plus Programmable Valves | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| October 14, 2022 | K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | JXG | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| August 22, 2022 | K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| July 20, 2022 | K221037 | TruDi Shaver Blade | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| July 15, 2022 | K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 2, 2021 | K203745 | AURORA Evacuator +Coag | GEI | Substantially Equivalent | Rebound Therapeutics | accessdata.fda.gov |
| May 14, 2021 | K210942 | MicroFrance Monopolar and Bipolar Electrosurgical Instruments | GEI | Substantially Equivalent | Integra Microfrance | accessdata.fda.gov |
| April 30, 2021 | K210993 | CereLink ICP Monitor | GWM | Substantially Equivalent | Integra Lifesciences Production Corporation | accessdata.fda.gov |
| November 20, 2020 | K193346 | Codman Surgical Patties & Strips | HBA | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| August 27, 2020 | K201115 | Next Generation Balloon Dilation System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| August 12, 2020 | K201174 | TruDi Curette | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| March 23, 2020 | K193453 | TruDi Probe | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| January 30, 2020 | K192397 | TruDi Navigation System | PGW | Substantially Equivalent | Biosense Webster | accessdata.fda.gov |
| December 6, 2019 | K191861 | Aurora Surgiscope System | GWG | Substantially Equivalent | Rebound Therapeutics | accessdata.fda.gov |
| November 22, 2019 | K191734 | MatriStem UBM Pericardial Patch | PSQ | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| October 25, 2019 | K192725 | Cytal Wound Matrix 3-Layer | KGN | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| October 11, 2019 | K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 3, 2019 | K183438 | Geomed Vascular Dilators | DWP | Substantially Equivalent | Geomed Medizin-Technik GmbH & Co. | accessdata.fda.gov |
| May 3, 2019 | K190532 | TruDi NAV Wire | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| May 3, 2019 | K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| April 19, 2019 | K183090 | Relieva Tract Balloon Dilation System | QGK | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| April 11, 2019 | K183526 | Codman Electrosurgical Generator, Foot Pedal | GEI | Substantially Equivalent | Kls Martin GmbH + Co. KG | accessdata.fda.gov |
| April 1, 2019 | K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| February 12, 2019 | K190075 | Aurora Evacuator | GEI | Substantially Equivalent | Rebound Therapeutics | accessdata.fda.gov |
| February 7, 2019 | K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | FTM | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| January 20, 2019 | K183581 | Codman Disposable Perforators | HBF | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| January 11, 2019 | K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | GWM | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| December 7, 2018 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 27, 2018 | K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable | GEI | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 20, 2018 | K182265 | CodMan Certas Plus Programmable Valve | JXG | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| October 25, 2018 | K181902 | Codman Certas Plus Electronic Tool Kit | JXG | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| August 2, 2018 | K181094 | Polydioxanone Surgical Scaffold | FTL | Substantially Equivalent | Lntegra Lifesciences | accessdata.fda.gov |
| July 20, 2018 | K180948 | TruDi NAV Suction Instruments | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| March 10, 2018 | K173628 | Acclarent ENT Navigation System | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| November 8, 2017 | K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 16, 2017 | K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 6, 2017 | K172399 | MicroMatrix | KGN | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| September 5, 2017 | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| August 31, 2017 | K170599 | SureFlo EVD Catheter | JXG | Substantially Equivalent | Arkis Biosciences, Inc. | accessdata.fda.gov |
| June 8, 2017 | K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | FTM | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| June 7, 2017 | K171357 | SurgiMend PRS Meshed, Revize-X | OXH | Substantially Equivalent | Integra Lifesciences Corporation (Owner of Tei Biosciences) | accessdata.fda.gov |
| February 16, 2017 | K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | FTM | Substantially Equivalent | Tei Biosciences, Inc. | accessdata.fda.gov |
| January 6, 2017 | K163457 | NeuraGen 3D Nerve Guide Matrix | JXI | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 6, 2016 | K160811 | CRW STEREOTACTIC SYSTEM | HAW | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 1, 2016 | K163106 | CODMAN Integrated Bipolar Cord and Tubing Set | GEI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| November 2, 2016 | K161370 | Durepair Dura Regeneration Matrix | GXQ | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| October 28, 2016 | K162437 | Codman EDS3 CSF External Drainage System | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 26, 2016 | K162469 | CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps | GEI | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| October 24, 2016 | K161701 | CARTO ENT System | PGW | Substantially Equivalent | Biosense Webster | accessdata.fda.gov |
| October 24, 2016 | K161698 | Relieva UltirraNav Sinus Balloon Catheter | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| October 24, 2016 | K161697 | Acclarent NavWire Sinus Navigation Guidewire | PGW | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| October 14, 2016 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 22, 2016 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 16, 2016 | DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | PNZ | Unknown | Acclarent, Inc. | accessdata.fda.gov |
| August 19, 2016 | K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit | GWM | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| June 28, 2016 | K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape | JOJ | Substantially Equivalent | Canadian Technical Tape, Ltd. | accessdata.fda.gov |
| March 14, 2016 | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| March 4, 2016 | K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| February 22, 2016 | K153690 | PriMatrix Dermal Repair Scaffold | KGN | Substantially Equivalent | Tei Biosciences, Inc. | accessdata.fda.gov |
| February 12, 2016 | K153341 | Relieva Scout Multi-Sinus Dilation System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| January 22, 2016 | K152670 | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables | GWM | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| December 8, 2015 | K152721 | Cytal Wound Matrix | KGN | Substantially Equivalent | Acell, Inc. | accessdata.fda.gov |
| November 19, 2015 | K150985 | Medihoney Wound Gel | FRO | Substantially Equivalent | Derma Sciences, Inc. | accessdata.fda.gov |
| October 27, 2015 | K152152 | Codman Certas Plus Programmable Valve | JXG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| April 22, 2015 | K143541 | Relieva SpinPlus Balloon Sinuplasty System | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| April 16, 2015 | K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs | HAE | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| April 7, 2015 | K150172 | ACCLARENT SE Inflation Device | LRC | Substantially Equivalent | Acclarent, Inc. | accessdata.fda.gov |
| February 20, 2015 | K150024 | Bissinger Monopolar Cables | GEI | Substantially Equivalent | Guenter Bissinger Medizintechnik GmbH | accessdata.fda.gov |
| February 19, 2015 | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | JXG | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| January 6, 2015 | K140722 | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 24, 2014 | K142238 | MAYFIELD Skull Clamp | HBL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 6, 2014 | K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 30, 2014 | K142414 | Miltex N-Tralig Intraligamentary Syringe | EJI | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| August 12, 2014 | K131407 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
| April 11, 2014 | K134047 | JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS | HCZ | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 28, 2013 | K131446 | INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES | DQR | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| August 30, 2013 | K131184 | INTEGRA LICOX PTO2 MONITOR | GWM | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| May 14, 2013 | K123077 | VASCULAR CLAMPS | DXC | Substantially Equivalent | Hebumedical GmbH | accessdata.fda.gov |
| April 23, 2013 | K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP | HBL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 11, 2012 | K120012 | INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS | GCJ | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 10, 2012 | K121573 | INTEGRA CAMINO ICP MONITOR | GWM | Substantially Equivalent | Intrgra Lifesciences Corporation | accessdata.fda.gov |
| August 3, 2012 | K122118 | HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| June 15, 2012 | K120600 | DURAGEN SECURE DURAL REGNERATION MATRIX | GXQ | Substantially Equivalent | Integra Life Sciences | accessdata.fda.gov |
| June 7, 2012 | K112090 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
| May 24, 2012 | K120633 | MAYFIELD SKULL CLAMP | HBL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| February 9, 2012 | K113104 | INTEGRA WOUND MATRIX (THIN) | KGN | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| February 8, 2012 | K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS | KNF | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| January 20, 2012 | K112662 | MICROFRANCE(R) WORMALD VASCULAR CLAMP | DXC | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 4, 2009 | P080013 | DURASEAL EXACT SPINE SEALANT SYSTEM | NQR | 28 | February 27, 2026 | accessdata.fda.gov |
| April 7, 2005 | P040034 | DURASEAL DURAL SEALANT SYSTEM | NQR | 38 | February 27, 2026 | accessdata.fda.gov |
| March 1, 1996 | P900033 | INTEGRA DERMAL REGENERATION TEMPLATE | MGR | 109 | September 18, 2026 | accessdata.fda.gov |
| November 8, 1985 | P850010 | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE | LMF | 113 | September 18, 2026 | accessdata.fda.gov |
| November 8, 1985 | P840062 | COLLACOTE(TM) | LPG | 94 | September 18, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 124.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 5, 2026 | 99193 | Class II | Ongoing | OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. | accessdata.fda.gov |
| April 10, 2026 | 98752 | Class II | Ongoing | Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) | Out-of-specification endotoxin result that did not meet the acceptance criteria. | accessdata.fda.gov |
| March 19, 2026 | 98607 | Class II | Ongoing | Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. | Increased rate of out-of-specification endotoxin results. | accessdata.fda.gov |
| March 6, 2026 | 98476 | Class II | Ongoing | CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system. | Software issue that renders the touch screen unresponsive. | accessdata.fda.gov |
| January 16, 2026 | 98175 | Class II | Ongoing | MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated fo | Potential packaging failures, which could lead to a breach in the sterile barrier. | accessdata.fda.gov |
| December 12, 2025 | 98091 | Class II | Ongoing | Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pres | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. | accessdata.fda.gov |
| October 3, 2025 | 97677 | Class II | Ongoing | TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01 | It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy. | accessdata.fda.gov |
| September 26, 2025 | 97623 | Class I | Ongoing | CODMAN Disposable Perforator 11mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. | accessdata.fda.gov |
| August 5, 2025 | 97404 | Class II | Ongoing | Brand Name: MediHoney Product Name: MediHoney Paste Model/Catalog Number: 31505 Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey | Packaging failures were identified which could lead to a breach in the sterile barrier. | accessdata.fda.gov |
| May 23, 2025 | 96965 | Class I | Ongoing | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids. | Lack of sterility assurance. | accessdata.fda.gov |
| May 22, 2025 | 96934 | Class I | Ongoing | Extended Tip Applicator, 8CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. | accessdata.fda.gov |
| April 11, 2025 | 96694 | Class I | Ongoing | CODMAN Disposable Perforator, 14mm. Cranial perforator. | Inadequate weld that can potentially cause the product to disassemble. | accessdata.fda.gov |
| April 4, 2025 | 96672 | Class II | Ongoing | INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. | accessdata.fda.gov |
| February 6, 2025 | 96216 | Class II | Ongoing | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80 | Possibility for the obturator to break (separate). | accessdata.fda.gov |
| January 10, 2025 | 96109 | Class II | Ongoing | Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney Gel with Active Leptospermum Honey is a moist dressing made of | Potential that the induction seal is not completely sealed to the device tube packaging. | accessdata.fda.gov |
| December 16, 2024 | 95951 | Class II | Ongoing | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. | accessdata.fda.gov |
| September 26, 2024 | 95466 | Class II | Ongoing | Duraform Dural Graft Implant, Size 3x3, Model Number 80-1477US Lot CT007694 | Out of specification endotoxin levels. | accessdata.fda.gov |
| September 20, 2024 | 95432 | Class II | Ongoing | MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties have a suture string attached for ease in | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | accessdata.fda.gov |
| September 13, 2024 | 95397 | Class II | Ongoing | MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535) | There is a potential for pinholes in the applicator pouch film which creates a sterility concern. | accessdata.fda.gov |
| July 9, 2024 | 94955 | Class II | Ongoing | TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery | Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system. | accessdata.fda.gov |
| June 7, 2024 | 94804 | Class II | Ongoing | AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager. | Potential sheath damage that could lead to tissue damage and/or track hemorrhage. | accessdata.fda.gov |
| May 29, 2024 | 94724 | Class II | Ongoing | CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL o | Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment | accessdata.fda.gov |
| May 7, 2024 | 94622 | Class II | Ongoing | CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar phy | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility. | accessdata.fda.gov |
| April 17, 2024 | 94453 | Class II | Ongoing | Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. | accessdata.fda.gov |
| January 19, 2024 | 93881 | Class II | Ongoing | Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain. | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | accessdata.fda.gov |
| October 19, 2023 | 93356 | Class II | Ongoing | Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND | Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device | accessdata.fda.gov |
| October 5, 2023 | 93084 | Class I | Ongoing | CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU. | Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue. | accessdata.fda.gov |
| April 11, 2023 | 92180 | Class II | Ongoing | Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607 | Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection. | accessdata.fda.gov |
| December 2, 2022 | 91280 | Class II | Ongoing | Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 | Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever. | accessdata.fda.gov |
| June 22, 2022 | 90457 | Class I | Ongoing | CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor. | Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment. | accessdata.fda.gov |
| February 28, 2022 | 89830 | Class II | Ongoing | Integra Universal Flexible Arm part number REF 1362275 | Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition. | accessdata.fda.gov |
| January 21, 2022 | 89618 | Class II | Terminated | Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614 | Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur | accessdata.fda.gov |
| June 1, 2021 | 88312 | Class II | Terminated | CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037 | Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier | accessdata.fda.gov |
| March 17, 2021 | 87596 | Class II | Terminated | CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524 | Incorrect labeling, Catheter did not have the required holes and markings | accessdata.fda.gov |
| December 14, 2020 | 86986 | Class II | Terminated | Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073 | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa | accessdata.fda.gov |
| November 11, 2020 | 86845 | Class II | Terminated | Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000 | Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram | accessdata.fda.gov |
| August 4, 2020 | 86240 | Class II | Terminated | 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. T | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. | accessdata.fda.gov |
| February 7, 2020 | 84960 | Class III | Terminated | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the | Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. | accessdata.fda.gov |
| October 21, 2019 | 84216 | Class II | Terminated | C7000 - CUSA Clarity Ultrasonic Tissue Ablation System | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying. | accessdata.fda.gov |
| September 12, 2019 | 83831 | Class II | Ongoing | Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. | There is a potential for a progressive decline in observed ICP readings of the monitor during use. | accessdata.fda.gov |
| August 7, 2019 | 83418 | Class II | Terminated | Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. # | A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument | accessdata.fda.gov |
| July 19, 2019 | 83485 | Class II | Terminated | Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedur | Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected | accessdata.fda.gov |
| April 8, 2019 | 82659 | Class I | Terminated | MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTo | The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. | accessdata.fda.gov |
| March 8, 2019 | 82377 | Class II | Terminated | Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU | accessdata.fda.gov |
| June 29, 2018 | 80421 | Class II | Terminated | MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between su | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | accessdata.fda.gov |
| March 6, 2018 | 79765 | Class II | Terminated | Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abr | Incorrect gel part number listed in a master manufacturing record | accessdata.fda.gov |
| December 20, 2017 | 79597 | Class II | Terminated | The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm | Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required. | accessdata.fda.gov |
| September 26, 2017 | 79171 | Class II | Terminated | Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated fo | A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the initial use once the footswitch is connected to the console and after the user primes the system, performs a handpiece test, and enters the | accessdata.fda.gov |
| August 18, 2017 | 79636 | Class II | Terminated | TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 | A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications. | accessdata.fda.gov |
| March 3, 2017 | 76693 | Class II | Terminated | Panta Nail, Rx only, Sterile | Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended. | accessdata.fda.gov |
| January 25, 2017 | 76408 | Class III | Terminated | The UNI-CP System; Model Number: 330230SND. | The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect. | accessdata.fda.gov |
| January 20, 2017 | 76290 | Class II | Terminated | Integra Cadence Total Ankle System | Posterior tibial fractures have been reported. | accessdata.fda.gov |
| August 23, 2016 | 75065 | Class II | Terminated | Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hy | During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. | accessdata.fda.gov |
| July 21, 2016 | 74855 | Class II | Terminated | Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction. | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw". | accessdata.fda.gov |
| July 20, 2016 | 74757 | Class II | Terminated | Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219 | Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site. | accessdata.fda.gov |
| July 1, 2016 | 74583 | Class II | Terminated | Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation. | The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold. | accessdata.fda.gov |
| June 17, 2016 | 74613 | Class II | Terminated | Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invas | Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon. | accessdata.fda.gov |
| May 20, 2016 | 74224 | Class II | Terminated | K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by | The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter. | accessdata.fda.gov |
| May 10, 2016 | 74114 | Class II | Terminated | TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the | As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges from prior lot numbers manufactured before Integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. The number should be 4 | accessdata.fda.gov |
| April 29, 2016 | 74173 | Class II | Terminated | Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced j | As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly. The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium. | accessdata.fda.gov |
| March 7, 2016 | 73684 | Class II | Terminated | Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments. | accessdata.fda.gov |
| August 21, 2015 | 72068 | Class II | Terminated | Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System. | Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing. | accessdata.fda.gov |
| May 27, 2015 | 71343 | Class II | Terminated | Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter wi | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter. | accessdata.fda.gov |
| April 14, 2015 | 71027 | Class II | Terminated | The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions. | accessdata.fda.gov |
| March 13, 2015 | 70758 | Class II | Terminated | Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a seale | A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe). | accessdata.fda.gov |
| November 7, 2014 | 69803 | Class II | Terminated | Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX | Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value. | accessdata.fda.gov |
| November 6, 2014 | 69719 | Class II | Terminated | Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Siz | Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque. | accessdata.fda.gov |
| October 24, 2014 | 69596 | Class II | Terminated | Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder Syst | A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be. | accessdata.fda.gov |
| September 29, 2014 | 69541 | Class II | Terminated | Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the cons | Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner. | accessdata.fda.gov |
| August 18, 2014 | 69251 | Class II | Terminated | Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 | Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device. | accessdata.fda.gov |
| July 9, 2014 | 68742 | Class II | Terminated | Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment. | accessdata.fda.gov |
| June 27, 2014 | 68679 | Class II | Terminated | Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cerv | Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery. | accessdata.fda.gov |
| June 11, 2014 | 68519 | Class II | Terminated | Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 905 | LED battery chargers may prematurely fail and will not charge the LED battery as intended | accessdata.fda.gov |
| June 9, 2014 | 68498 | Class II | Terminated | MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to | Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique. | accessdata.fda.gov |
| May 19, 2014 | 68330 | Class II | Terminated | Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050, Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that | This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine. | accessdata.fda.gov |
| April 16, 2014 | 68159 | Class II | Terminated | Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provi | Integra LifeSciences has identified through a small number of complaints that some lot numbers of Licox Test Kits (Catalog Number BC10R) may provide erroneous "calibration test failure" message when they are used with the Licox PtO2 Monitor (LCSO2, or may provide an erroneous out of range result with the Licox CMP Brain Tissue Oxygen and Temperature Monitor | accessdata.fda.gov |
| March 10, 2014 | 67902 | Class II | Terminated | Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to prope | Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert. | accessdata.fda.gov |
| January 22, 2014 | 67350 | Class II | Terminated | Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a tempora | Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some complaints did indicate the surgery was slightly prolonged while the additional driver provided in the kit was retrieved a | accessdata.fda.gov |
| December 5, 2013 | 67406 | Class II | Terminated | Integra Cusa Excel Rx Only CEM" Nosecone for CUSA Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generato | The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position. | accessdata.fda.gov |
| November 26, 2013 | 67094 | Class II | Terminated | Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 seri | Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values co | accessdata.fda.gov |
| November 13, 2013 | 67025 | Class II | Terminated | Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL Provides access to the lateral cerebral ventricles via hyp | Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open | accessdata.fda.gov |
| August 29, 2013 | 66449 | Class II | Terminated | Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold | An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure. | accessdata.fda.gov |
| June 11, 2013 | 65742 | Class II | Terminated | Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integ | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit. | accessdata.fda.gov |
| June 3, 2013 | 65362 | Class III | Terminated | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone l | As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA. | accessdata.fda.gov |
| February 12, 2013 | 64357 | Class II | Terminated | Integra(R) Jarit(R) Monopolar Cable (Catalogue No. ). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon | Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments. | accessdata.fda.gov |
| February 1, 2013 | 65503 | Class II | Terminated | Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metat | The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. | accessdata.fda.gov |
| January 7, 2013 | 64318 | Class II | Terminated | Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. | There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with | accessdata.fda.gov |
| December 21, 2012 | 64185 | Class II | Terminated | MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD Base Units are intended to be used to support a p | Integra determined there is a possibility that the Base Units may break during use. | accessdata.fda.gov |
| December 10, 2012 | 63856 | Class II | Terminated | Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer p | Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT. | accessdata.fda.gov |
| June 14, 2012 | 62728 | Class II | Terminated | The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and | Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. None of the complaints resulted in patient injuries but in some cases resulted in an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that any potential for risk would be transie | accessdata.fda.gov |
| February 9, 2012 | 61655 | Class II | Terminated | Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition | Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery. | accessdata.fda.gov |
| January 6, 2012 | 61183 | Not yet classified | Terminated | Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR System includes a range of instruments for endoscopic approach to | The firm received several complaints from customers reporting that the blade of the EGR system may not retract back into the device following surgery. The firm attributes this problem to user error or improper surgical technique on the part of the physician. | accessdata.fda.gov |
| December 21, 2011 | 61125 | Not yet classified | Terminated | Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a replenishment part indi | Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm. | accessdata.fda.gov |
| November 17, 2011 | 61041 | Not yet classified | Terminated | Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part #, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys p | During 6/30/2010 to 8/17/2011 the firm received five (5) incident complaints of breakage of the threaded part of the compression guide which potentially occurred when: 1) a compression is applied between talus and tibia. (Step 3 of the product description) or when 2) the surgeon screws the compression guide into the plate which most likely was attributed to | accessdata.fda.gov |
| October 14, 2011 | 60300 | Not yet classified | Terminated | Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgic | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. | accessdata.fda.gov |
| October 11, 2011 | 61717 | Class II | Terminated | Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a b | The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French | accessdata.fda.gov |
| October 10, 2011 | 60214 | Not yet classified | Terminated | Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illuminat | Headlight assembly (module) may become loose and separate from the headband assembly | accessdata.fda.gov |
| May 19, 2011 | 61352 | Not yet classified | Terminated | Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for easy size identification | The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail. | accessdata.fda.gov |
| May 19, 2011 | 58995 | Not yet classified | Terminated | Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119. | Kits contain protective wipes that may be contaminated with Bacillus cereus. | accessdata.fda.gov |
| March 11, 2011 | 58333 | Not yet classified | Terminated | Universal Power Supply Units, Part Number DP0007 and DP0800, for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. The Integra Padgett Dermatomes are intended for use | Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient. | accessdata.fda.gov |
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Updated July 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.