Data / Medical devices / United States / Linvatec Corporation
Linvatec Corporation: FDA-registered device maker in Largo, FL, United States, 172 510(k) clearances
Linvatec Corporation is registered with the FDA (registration 1017294) in Largo, FL, United States. It lists 89 device types. The FDA files 172 510(k) clearances under its listings, the newest dated May 13, 2026. 35 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1017294
- Address
- 11311 Concept Boulevard, Largo, FL, United States, 33773
- Owner or operator
- CONMED CORPORATION (1317214)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 22, 1992
- Registered through
- 2027
- Brand names listed
- 10K, Linvatec, 10k tubesets, 24k tubesets, 24K Irrigation, 24K Shaver sensor, 24K Tips Tubing Set, 3CCD EYECUP HEAD, 3DHD Light Guide, 3DHD Stereoscope System and more
Devices it lists
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 172.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 13, 2026 | K261363 | Y-Knotless Flex Anchors | MBI | Substantially Equivalent | CONMED Corporation | accessdata.fda.gov |
| January 29, 2026 | K253763 | Y-Knotless Flex Anchors | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 15, 2025 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | MAI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 18, 2025 | K251530 | CONMED Argo Knotless® Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 7, 2025 | K250395 | BioBrace ® RC Delivery System | ORQ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| November 27, 2024 | K242187 | BioBrace® | OWW | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 29, 2024 | K241906 | BioBrace® Reinforced Implant | OWW | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 5, 2024 | K240090 | Argo Knotless GENESYS Anchor | MAI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 27, 2023 | K230547 | PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 13, 2022 | K220757 | Argo Knotless SP Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 13, 2022 | K220186 | Zone Specific AIM | GAT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 30, 2021 | K203267 | The BioBrace Implant | OWW | Substantially Equivalent | Biorez, Inc. | accessdata.fda.gov |
| July 8, 2020 | K201593 | Looking Glass 4K Integrated Visualization System | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 22, 2020 | K193606 | Y-Knot OneStep Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 3, 2019 | K191204 | Infinity Fixation System | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 28, 2019 | K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | HTN | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| June 28, 2019 | K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | HTN | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 18, 2019 | K190333 | Paradigm All-Suture Anchor 1.8mm, White/Black #2 | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 22, 2019 | K182955 | EZStart Interference Screw | HWC | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 8, 2019 | K182439 | TruShot with Y-Knot Shallow All-Suture Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 4, 2019 | K182621 | CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 19, 2018 | K182446 | TruShot with Y-Knot All-Suture Anchor | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| November 14, 2018 | K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | HRX | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 19, 2018 | K180763 | CuffLink Implant System Biocomposite | MAI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 16, 2018 | K172516 | SurgiQuest AIRSEAL iFS System | HIF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| October 4, 2017 | K172671 | HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 8, 2017 | K171725 | CuffLink Implant System | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 17, 2017 | K170501 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver | MAI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 25, 2017 | K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 9, 2016 | K161017 | True HD 3MOS Camera System | GCJ | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| March 31, 2016 | K152969 | ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY | KCT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 29, 2015 | K152860 | HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| July 9, 2015 | K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| April 23, 2015 | K142535 | ConMed Mixing and Delivery Kit | FMF | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| September 12, 2014 | K142134 | C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES | HTY | Substantially Equivalent | Conmed Corporation, Largo | accessdata.fda.gov |
| July 10, 2014 | K140101 | ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS | GCJ | Substantially Equivalent | Ab Medica Sas | accessdata.fda.gov |
| March 28, 2014 | K133116 | VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC | KCT | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| January 3, 2014 | K133224 | Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES | MBI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 9, 2013 | K132783 | EXOSHAPE DUO SOFT TISSUE FASTENER | MBI | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| August 22, 2013 | K132169 | SURGIQUEST AIRSEAL IFS | GCJ | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| July 2, 2013 | K131035 | Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM | MBI | Substantially Equivalent | Linvatec Corporation D/B/A Conmed Linvatec | accessdata.fda.gov |
| March 29, 2013 | K130497 | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | HBC | Substantially Equivalent | Linvatec Corporation D/B/A Conmed Linvatec | accessdata.fda.gov |
| August 22, 2012 | K121890 | GENESYS PRESSFT SUTURE ANCHOR | MAI | Substantially Equivalent | Linvatec Corporation D/B/A Conmed Linvatec | accessdata.fda.gov |
| July 3, 2012 | K121336 | MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 | HIF | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| June 7, 2012 | K120841 | APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR | MBI | Substantially Equivalent | Kfx Medical | accessdata.fda.gov |
| November 2, 2011 | K112965 | NANO SUTURE ANCHOR | MBI | Substantially Equivalent | Linvatec Corporation D/B/A Conmed Linvatec | accessdata.fda.gov |
| August 8, 2011 | K111779 | Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 | MBI | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| June 10, 2011 | K111471 | EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) | MBI | Substantially Equivalent | Medshape Solutions, Inc. | accessdata.fda.gov |
| May 25, 2011 | K103692 | SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 | HIF | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| December 21, 2010 | K102410 | MATRYX INTERFERENCE SCREW (5.0-6.5MM) | HWC | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| November 23, 2010 | K102339 | CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE | GAT | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| November 8, 2010 | K101808 | SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER | HWC | Substantially Equivalent | Medshape Solutions | accessdata.fda.gov |
| August 30, 2010 | K101810 | 3DHJD CAMERA SYSTEM MODEL | GCJ | Substantially Equivalent | Vision Systems Group, A Division of Viking Systems | accessdata.fda.gov |
| August 26, 2010 | K101100 | CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 | MAI | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| May 10, 2010 | K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED | GAT | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| May 5, 2010 | K100180 | SURGIQUEST ANCHORPORT SIL KIT | GCJ | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| November 5, 2009 | K092504 | SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM | GCJ | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| October 19, 2009 | K092898 | CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES | MAI | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| June 29, 2009 | K090560 | CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS | KCT | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| June 23, 2009 | K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | MBI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| June 22, 2009 | K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR | MAI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| April 10, 2009 | K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES | MAI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| March 27, 2009 | K083161 | ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) | HRX | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| February 25, 2009 | K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- | GEI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| December 15, 2008 | K083211 | AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM | GCJ | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| September 5, 2008 | K080531 | CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY | KCT | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| July 14, 2008 | K072291 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR | HWC | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| June 20, 2008 | K081585 | ENDOSCOPY VIDEO CAMERA SYSTEM | FET | Substantially Equivalent | Vision Systems Group, A Division of Viking Systems | accessdata.fda.gov |
| June 18, 2008 | K081477 | LUXTEC MLX LIGHT SOURCE | FCW | Substantially Equivalent | Integra Luxtec, Inc. | accessdata.fda.gov |
| April 2, 2008 | K080444 | CONMED LINVATEC OSPREY DRILL SYSTEM | HBC | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| January 7, 2008 | K073481 | THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES | MBI | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| October 24, 2007 | K072706 | MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL | HRX | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| August 21, 2007 | K070780 | CONMED LINVATEC XO BUTTON | MBI | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| August 20, 2007 | K070376 | CONMED LINVATEC 300W XENON LIGHT SOURCE | GCT | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| April 2, 2007 | K070233 | CONMED LINVATEC SMART GUARD IRRIGATOR | HRX | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| March 14, 2007 | K063859 | SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA | GCJ | Substantially Equivalent | Surgiquest, Inc. | accessdata.fda.gov |
| March 2, 2007 | K063588 | MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 | HWC | Substantially Equivalent | Conmed Linvatec Biomaterials | accessdata.fda.gov |
| January 31, 2007 | K063326 | CONMED LINVATEC 24K IRRIGATION SYSTEM | HRX | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| December 5, 2006 | K063457 | TRUEHD (1080P) DIGITAL CAMERA SYSTEM | GCJ | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| October 16, 2006 | K052992 | CONMED LINVATEC INSTRUMENT STERILIZATION TRAY | FRG | Substantially Equivalent | Conmed Linvatec | accessdata.fda.gov |
| February 15, 2006 | K053389 | AESCULAP STERILCONTAINER SYSTEM | FRG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| August 25, 2005 | K052080 | MATRYX INTERFERENCE SCREW | HWC | Substantially Equivalent | Linvatec Biomaterials, Inc. | accessdata.fda.gov |
| May 17, 2005 | K050519 | ADVANCED TURBO DRIVE SYSTEM | GEY | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| March 25, 2005 | K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET | HWC | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| March 24, 2005 | K050163 | HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| March 2, 2005 | K050227 | THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER | MBI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| February 3, 2005 | K050161 | SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY | GEI | Substantially Equivalent | Conmed Electrosurgery | accessdata.fda.gov |
| January 19, 2005 | K043106 | PINN-ACL CROSSPIN | HTY | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| November 4, 2004 | K042778 | BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE | HWC | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| July 22, 2004 | K041713 | SUPER REVO HERCULINE SUTURE ANCHOR | MBI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| February 11, 2004 | K033573 | LINVATEC 10K IRRIGATION SYSTEM | HRX | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| December 31, 2003 | K033804 | BIOANCHOR WITH DISPOSABLE DRIVER | HWC | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| December 15, 2003 | K033748 | TRIDENT RESECTION ABLATOR | GEI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| November 10, 2003 | K032607 | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 | DZI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| August 21, 2003 | K031994 | LINVATEC 300W XENON LIGHT SOURCE | GCT | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| July 25, 2003 | K031981 | 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 | MAI | Substantially Equivalent | Linvatec Biomaterials, Ltd. | accessdata.fda.gov |
| June 4, 2003 | K031098 | 3-CCD DIGITAL CAMERA SYSTEM | GCJ | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| June 3, 2003 | K030720 | ULTRABLATOR ELECTRODE | GEI | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
| June 28, 2002 | K021290 | VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 | GCJ | Substantially Equivalent | Vista Medical Technologies, Inc. | accessdata.fda.gov |
| June 11, 2002 | K013131 | BIOSCREW XTRALOK | HWC | Substantially Equivalent | Linvatec Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 30, 2013 | 65320 | Class II | Terminated | REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures. | Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site | accessdata.fda.gov |
| March 18, 2013 | 64647 | Class II | Terminated | Ref: VP1600 HD Still Capture System ConMed Linvatec. Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. | The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue. | accessdata.fda.gov |
| March 6, 2013 | 65166 | Class II | Terminated | GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures | Incorrect blue/white suture was used. | accessdata.fda.gov |
| January 24, 2013 | 64367 | Class III | Terminated | D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone | The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance. | accessdata.fda.gov |
| November 15, 2012 | 63823 | Class II | Terminated | ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch | ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm. | accessdata.fda.gov |
| July 6, 2012 | 62665 | Class II | Terminated | PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA** | ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. | accessdata.fda.gov |
| June 26, 2012 | 63115 | Class II | Terminated | "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant. | accessdata.fda.gov |
| April 10, 2012 | 63077 | Class II | Terminated | "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tu | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package. | accessdata.fda.gov |
| April 9, 2012 | 63090 | Class II | Terminated | "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone. | ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle. | accessdata.fda.gov |
| August 12, 2011 | 62395 | Class II | Terminated | CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. | ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion. | accessdata.fda.gov |
| July 1, 2011 | 63107 | Class II | Terminated | Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or | ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents. | accessdata.fda.gov |
| May 20, 2011 | 63009 | Class II | Terminated | REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source | Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures. | accessdata.fda.gov |
| January 26, 2011 | 58936 | Not yet classified | Terminated | "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERIL | ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable driver may have the incorrect color handle (red versus black). | accessdata.fda.gov |
| November 30, 2010 | 58013 | Not yet classified | Terminated | POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Made in USA*** To cut sof | On Nov 30, 2010 ConMed Linvatec, Largo, FL recalled their Micro Sagittal Blade, Fine Lot number 180209, Product Number 5023-138. Some units of Micro Sagittal Blade, Fine from Lot 180209 may have compromised seals in the sterile packaging. | accessdata.fda.gov |
| September 17, 2010 | 58009 | Not yet classified | Terminated | REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA*** Catalog No Product VPN6528 Articulating | If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement. | accessdata.fda.gov |
| September 10, 2010 | 58017 | Not yet classified | Terminated | REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 33773-4900*** For use in conjunction with the ConMed Linvatec 24k P | On 09/13/2010 ConMed Linvatec, Largo, FL initiated a recall on 24k100 Arthroscopy Outflow/Suction Tube Set used with the ConMed Linvatec 24k Pump. The 24k100 Arthroscopy Outflow/Suction Tubing Set Lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field. | accessdata.fda.gov |
| August 5, 2010 | 56441 | Not yet classified | Terminated | GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only. | ConMed Linvatec, Largo, FL is recalling ConMed Linvatec 9263A,4.2mm Sterling Blade, Gator Meniscus Cutter, Lot Number 178026 for breech in the sterile barrier. | accessdata.fda.gov |
| July 6, 2010 | 56163 | Not yet classified | Terminated | REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System. CONMED LINVATEC, 11311 CONCEPT BLVD, LARG | ConMed Linvatec Largo, FL is recalling 87K Arthroscopy Tubing Set, Product Number 87100, Lots 0904151 to and including 1005201. Product may have a breach in the seal that could potentially compromise the sterility of the contents. | accessdata.fda.gov |
| February 23, 2010 | 56829 | Not yet classified | Terminated | The Power Cord Reel is labeled as follows: REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY. These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties MANUFACTU | ConMed Linvatec, Endoscopy Division, dba. ConMed Linvatec, Largo, Florida is recalling five products: (1.) Video Cart Premium 120 VAC (VP6501), (2.) Video Cart Multi-Specialty 120 VAC (VP6502), (3.) Video Cart Articulating Arm 120V (VP6504), (4.) Video Cart (VP8500), and (5.) Power Cord Assembly Self Retracting (VP6547). These products are being recalled due | accessdata.fda.gov |
| January 29, 2010 | 54561 | Not yet classified | Terminated | CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA. | There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage. | accessdata.fda.gov |
| January 28, 2010 | 54701 | Not yet classified | Terminated | REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in meniscal repairs. | This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents. | accessdata.fda.gov |
| November 12, 2009 | 59092 | Not yet classified | Terminated | REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Biomaterials, Ltd.Hermi | ConMed Linvatec, Largo, FL recalled catalog number, C9944A, lot # 95987, 2.9MM Full Radius Resector Blade in November 2009 because there was a possibility that the device was assembled with an incorrect outer tube. | accessdata.fda.gov |
| October 29, 2009 | 54521 | Not yet classified | Terminated | ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. | ConMed Linvatec is recalling Advantage, 2-Button Turbo Handpiece Catalog Number D9924. These products may self-activate due to moisture intrusion into the housing body. This issue has been isolated to products manufactured between June 7, 2004 and June 1, 2006. | accessdata.fda.gov |
| July 31, 2009 | 52812 | Not yet classified | Terminated | MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. ConMed Linvatec, 11311 Concept Blvd, Largo, FL 33773. The MC5057 Universal Cable, 12 ft, is used to connect electric handpieces to the power sourc | Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate. | accessdata.fda.gov |
| July 31, 2009 | 52811 | Not yet classified | Terminated | REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908. ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting and coagulation devic | ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns. | accessdata.fda.gov |
| July 31, 2009 | 52808 | Not yet classified | Terminated | Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.. The Arthro-Knife is a one piece disposable assembly comprised of a plastic handle with a retractable blade, sheath | ConMed has determined there is a possibility that the device may not fully retract once it is deployed. | accessdata.fda.gov |
| July 31, 2009 | 52804 | Not yet classified | Terminated | ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number | ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier. | accessdata.fda.gov |
| July 31, 2009 | 52803 | Not yet classified | Terminated | PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5250, PowerPro Battery Two Trigger | There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008. | accessdata.fda.gov |
| February 21, 2008 | 47848 | Not yet classified | Terminated | ConMed Linvatec Hall Surgical Blades, Sterile OSC/SAG BLADE, Catalog # U655, U554, and U551. ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades ar | Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices. | accessdata.fda.gov |
| August 9, 2007 | 38631 | Not yet classified | Terminated | ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773 | Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal. | accessdata.fda.gov |
| December 20, 2005 | 34438 | Not yet classified | Terminated | ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually. | The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. The nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations. | accessdata.fda.gov |
| August 30, 2005 | 33326 | Not yet classified | Terminated | ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces. | The footswitch may develop a system fault resulting in the self-activation of the handpiece it controls, or it may cause the handpiece to run intermittently or to revert to a default setting. | accessdata.fda.gov |
| February 22, 2005 | 31392 | Not yet classified | Terminated | Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver***STERILE***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 3 | Linvatec has determined that there is a possibility that the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices. | accessdata.fda.gov |
| August 26, 2004 | 29916 | Not yet classified | Terminated | Ultra Power Burs, Sterile, Single-Use. | The pouch containing the sterile product is not completely seal on all products. Therefore, the sterility of the device is questionable. | accessdata.fda.gov |
| January 24, 2003 | 25709 | Not yet classified | Terminated | Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053 | The Footswitch functions of the left and right foot pedals may be reversed in some units. | accessdata.fda.gov |
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Updated May 13, 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.