Data / Medical devices / United States / Synthes (USA) Products LLC
Synthes (USA) Products LLC: FDA-registered device maker in West Chester, PA, United States, 597 510(k) clearances and 2 PMA approvals
Synthes (USA) Products LLC is registered with the FDA (registration 3008812560) in West Chester, PA, United States. It lists 173 device types. The FDA files 597 510(k) clearances and 2 PMA approvals under its listings, the newest dated June 11, 2026. 74 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008812560
- Address
- 1301 Goshen Pkwy, West Chester, PA, United States, 19380
- Owner or operator
- SYNTHES (USA) Products LLC (2520274)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 16, 1978
- Registered through
- 2027
- Brand names listed
- 1.3 & 1.5MM CONTOURABLE TITANIUM (T, 1.5mm Headless Comp. Screws, 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM, 2.4/2.7mm VA-LCP Forefoot/Midfoot, 2.4MM CORTEX SCREW, SELF-TAPPING, 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES, 2.4mm VA LCP Volar DR Plates, 2.4mm VA-LCP Intercarpal Fusion 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 597.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 11, 2026 | K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | KTT | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| March 10, 2026 | K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | HRS | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| March 9, 2026 | K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | HRS | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| March 2, 2026 | K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | HRS | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| January 6, 2026 | K253178 | TRILEAP Plating System | HRS | Substantially Equivalent | Crossroads Extremity Systems | accessdata.fda.gov |
| November 12, 2025 | K243715 | Synthes Patient Specific Implants | GXN | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| March 28, 2025 | K241927 | Synthes Graphic Case & Tray System | KCT | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| August 1, 2024 | K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | HSB | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| July 26, 2024 | K233994 | VOLT Proximal Humerus 3.5 Plating System | HRS | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| May 9, 2024 | K233967 | DePuy Synthes MatrixSTERNUM Fixation System | HRS | Substantially Equivalent | Synthes GmbH | accessdata.fda.gov |
| March 21, 2024 | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| September 29, 2023 | K230591 | TriLEAP Plating System | HRS | Substantially Equivalent | Crossroads Extremity Systems | accessdata.fda.gov |
| July 26, 2023 | K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | KTT | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| September 20, 2022 | K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| January 28, 2022 | K212943 | SyntheCel Dura Repair | GXQ | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 2, 2021 | K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| May 25, 2021 | K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | KTT | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| April 8, 2021 | K210408 | DePuy Synthes Variable Angle Locking Patella Plating System | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| March 26, 2021 | K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| January 6, 2021 | K202810 | AutoStrut G2 | KTT | Substantially Equivalent | Orthospin, Ltd. | accessdata.fda.gov |
| December 16, 2020 | K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| September 23, 2020 | K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm | HSB | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| September 11, 2020 | K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| September 10, 2020 | K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | JEY | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| September 9, 2020 | K201578 | DePuy Synthes Variable Angle Locking Patella Plating System | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| September 3, 2020 | K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm | JDS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| July 24, 2020 | K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| April 6, 2020 | K200361 | Akros Scruture Anchor LisFranc Repair Kit | HTN | Substantially Equivalent | Akros Medical | accessdata.fda.gov |
| February 26, 2020 | K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | JDR | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| December 30, 2019 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | JEY | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| November 26, 2019 | K192745 | DePuy Synthes Trauma Screws | HWC | Substantially Equivalent | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 7, 2019 | K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| August 19, 2019 | K191342 | CrossRoads Screw System | HWC | Substantially Equivalent | Crossroads Extemity Systems, LLC | accessdata.fda.gov |
| August 16, 2019 | K190722 | TriMAX Implant System | JDR | Substantially Equivalent | Crossroads Extemity Systems, LLC | accessdata.fda.gov |
| August 14, 2019 | K191241 | AutoStrut | KTT | Substantially Equivalent | Orthospin | accessdata.fda.gov |
| July 23, 2019 | K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 21, 2019 | K190750 | DePuy Synthes Plates and Screws Portfolio | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| May 23, 2019 | K183054 | SYNMESH System | MQP | Substantially Equivalent | Depuy Synthes Spine | accessdata.fda.gov |
| May 17, 2019 | K183618 | Revolution Radial Head | KWI | Substantially Equivalent | Ignite Orthopedics, Inc. | accessdata.fda.gov |
| May 9, 2019 | K181933 | DePuy Synthes Sterilization Container System | KCT | Substantially Equivalent | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 3, 2019 | K190409 | MatrixRIB Fixation System | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| April 12, 2019 | K190658 | MIS Bunion Plating System | HRS | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| March 13, 2019 | K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional | FTM | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| March 13, 2019 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | MQN | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| December 26, 2018 | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| December 21, 2018 | K180821 | TruMatch Graft Cage - Long Bone | HRS | Substantially Equivalent | Synthes (Usa), LLC | accessdata.fda.gov |
| November 21, 2018 | K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | HWC | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| November 1, 2018 | K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | HRS | Substantially Equivalent | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 19, 2018 | K180213 | Titanium TomoFix Medial High Tibia Plate Anatomical | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| October 16, 2018 | K182154 | Depuy Synthes Femoral Neck System | KTT | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| August 9, 2018 | K181866 | MotoCLIP/HiMAX Step Staple Implant System | JDR | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| July 24, 2018 | K180544 | DePuy Synthes Static Staples | JDR | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 29, 2018 | K181410 | MotoCLIP/HiMAX Implant System | JDR | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| June 21, 2018 | K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins MR Conditional, DePuy Synthes Wire Mount MR Conditional, DePuy Synthes Cerclage Positioning Pin MR Conditional | JDQ | Substantially Equivalent | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 5, 2018 | K172872 | DePuy Synthes Femoral Neck System | KTT | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| February 12, 2018 | K173710 | MotoBAND CP Implant System | HWC | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| December 14, 2017 | K173550 | Akros FibuLink Syndesmosis Repair Kit | HTN | Substantially Equivalent | Akros Medical | accessdata.fda.gov |
| December 7, 2017 | K170818 | Craniomaxillofacial Distraction System (CMFD) | PBJ | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| November 14, 2017 | K172157 | DePuy Synthes Femoral Recon Nail System | HSB | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| September 28, 2017 | K170802 | TRAUMACEM V+ Injectable Bone Cement | LOD | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 30, 2017 | K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Modular Foot System MR Conditional, DePuy Synthes T-Plates MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) MR Conditional, DePuy Synthes Stainless S | HRS | Substantially Equivalent | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 8, 2017 | K162594 | Craniomaxillofacial Distraction System (CMFD) | MQN | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| March 29, 2017 | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins | JDP | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| February 16, 2017 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw | HWC | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| February 9, 2017 | K163046 | DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long | HRS | Substantially Equivalent | DePuy Synthes | accessdata.fda.gov |
| January 18, 2017 | K153587 | Taps for Resorbable Screws | HBG | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| January 10, 2017 | K162805 | Akros Fibulink Syndesmosis Repair Kit | HTN | Substantially Equivalent | Akros Medical | accessdata.fda.gov |
| November 10, 2016 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | KTT | Substantially Equivalent | Synthes USA, LLC | accessdata.fda.gov |
| November 3, 2016 | K161590 | MatrixRIB Fixation System | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| September 26, 2016 | K160167 | DePuy Synthes TFNA Augmentation System | HSB | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| May 5, 2016 | K153585 | Flip Button Suture Anchor | MBI | Substantially Equivalent | First Ray, LLC | accessdata.fda.gov |
| May 3, 2016 | K160118 | STROPP (Single Tunnel Repair of Plantar Plate) | MBI | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| April 22, 2016 | K160300 | MotoBand(TM) CP Implant System | HRS | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| February 26, 2016 | K153575 | Tyber Medical Trauma Screw | HWC | Substantially Equivalent | Tyber Medical, LLC | accessdata.fda.gov |
| December 11, 2015 | K152306 | MotoBand¿ CP Implant System | HRS | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| December 2, 2015 | K152239 | Zero-P Natural Plate System | KWQ | Substantially Equivalent | Synthes (Usa), LLC | accessdata.fda.gov |
| September 23, 2015 | K152072 | CrossRoads Screw System | HWC | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| September 4, 2015 | K151270 | CrossTIE Intraosseous Fixation System | HWC | Substantially Equivalent | Crossroads Extremity Systems, LLC | accessdata.fda.gov |
| August 21, 2015 | K150673 | SYNFIX Evolution Secured Spacer System | OVD | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 23, 2015 | K150796 | Dental Bone Cutting Instruments | DZJ | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 18, 2015 | K151276 | DePuy Synthes T-PAL Ti Spacer | MAX | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| May 28, 2015 | K143285 | Mandible External Fixator - MR Conditional | MQN | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| May 11, 2015 | K150125 | Elite Nitinol Fixation System | JDR | Substantially Equivalent | Biomedical Enterprises, Inc. | accessdata.fda.gov |
| March 30, 2015 | K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM | HRS | Substantially Equivalent | Synthes USA | accessdata.fda.gov |
| March 27, 2015 | K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | HBW | Substantially Equivalent | Depuy Synthes Companies of Johnson & Johnson | accessdata.fda.gov |
| March 23, 2015 | K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| January 20, 2015 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | NKG | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| January 16, 2015 | K143039 | CrossRoads Screw System | HWC | Substantially Equivalent | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | accessdata.fda.gov |
| January 16, 2015 | K143023 | Nitinol Compression Plating System | HRS | Substantially Equivalent | Biomedical Enterprises, Inc. | accessdata.fda.gov |
| January 8, 2015 | K141857 | CrossTie Intraosseous Fixation System | HWC | Substantially Equivalent | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | accessdata.fda.gov |
| November 18, 2014 | K142587 | Vertical Expandable Prosthetic Titanium Rib | MDI | Substantially Equivalent | Depuy Synthes Spine, Inc. | accessdata.fda.gov |
| November 17, 2014 | K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | JDR | Substantially Equivalent | Biomedical Enterprises, Inc. | accessdata.fda.gov |
| October 24, 2014 | K142727 | CrossCLIP Implant System | JDR | Substantially Equivalent | Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems | accessdata.fda.gov |
| October 17, 2014 | K141165 | MATRIXWAVE MMF SYSTEM | JEY | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| October 1, 2014 | K142460 | EXPEDIUM Spine System/Synapse System | KWP | Substantially Equivalent | Johnson and Johnson | accessdata.fda.gov |
| September 25, 2014 | K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | KWP | Substantially Equivalent | Synthes USA Products, LLC | accessdata.fda.gov |
| August 29, 2014 | K141796 | DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| August 14, 2014 | K130720 | SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| August 7, 2014 | K141241 | MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| June 13, 2014 | K140462 | MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) | GWO | Substantially Equivalent | Synthes (USA) Products, LLC | 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 |
|---|---|---|---|---|---|---|
| December 17, 2007 | P070001 | PRODISC TM-C TOTAL DISC REPLACEMENT | MJO | 27 | September 9, 2026 | accessdata.fda.gov |
| August 14, 2006 | P050010 | PRODISC -L TOTAL DISC REPLACEMENT DEVICE | MJO | 25 | September 2, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 25, 2026 | 98461 | Class II | Ongoing | 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. | A full lot swap between VOLT Locking Screw Tap 03. lot 68900P9 and Cortical Screw Tap 03. lot 68982P8, resulting in the bones taps having an incorrect thread. | accessdata.fda.gov |
| September 26, 2025 | 97693 | Class II | Ongoing | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | accessdata.fda.gov |
| April 25, 2024 | 94546 | Class II | Ongoing | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03. | Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay | accessdata.fda.gov |
| January 24, 2024 | 93924 | Class II | Ongoing | 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resec | Products not sterilized, sterility cannot be confirmed | accessdata.fda.gov |
| February 1, 2023 | 91702 | Class II | Ongoing | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length | accessdata.fda.gov |
| September 27, 2022 | 90918 | Class II | Ongoing | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery. | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. | accessdata.fda.gov |
| August 30, 2022 | 90842 | Class II | Ongoing | Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46. | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regar | accessdata.fda.gov |
| April 7, 2022 | 89972 | Class II | Ongoing | Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm | DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis. | accessdata.fda.gov |
| December 22, 2021 | 89428 | Class II | Ongoing | Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), R | Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection. | accessdata.fda.gov |
| November 19, 2020 | 86713 | Class II | Terminated | DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | accessdata.fda.gov |
| September 21, 2020 | 86545 | Class III | Terminated | DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights ena | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" | accessdata.fda.gov |
| July 21, 2020 | 86104 | Class II | Terminated | DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, | May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw | accessdata.fda.gov |
| September 16, 2019 | 83948 | Class II | Terminated | Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04. for use in spinal surgery | The subject product measures 4.0mm in diameter instead of 3.5mm. | accessdata.fda.gov |
| September 5, 2019 | 83991 | Class II | Terminated | MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spa | Modified outside of approved manufacturing process | accessdata.fda.gov |
| September 12, 2018 | 81152 | Class II | Terminated | 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04. DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones | The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length. | accessdata.fda.gov |
| May 4, 2018 | 80048 | Class II | Terminated | Synthes Torque Limiting Handle, Part Number 03. This device is used in systems indicated for fracture fixation. | The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely. | accessdata.fda.gov |
| April 2, 2018 | 79850 | Class II | Terminated | Retractor f/Sciatic Nerve; Part number: 03.; UDI: 10886982070623 | There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle. | accessdata.fda.gov |
| March 5, 2018 | 79754 | Class II | Terminated | Part no., Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set | Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length. | accessdata.fda.gov |
| August 10, 2017 | 79043 | Class II | Terminated | Norian Drillable Inject | The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit. | accessdata.fda.gov |
| July 26, 2017 | 79157 | Class II | Terminated | 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery. | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | accessdata.fda.gov |
| July 21, 2017 | 78958 | Class II | Terminated | 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile | The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. | accessdata.fda.gov |
| January 31, 2017 | 76487 | Class II | Terminated | PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03. and 03.. Used to hold the disc segment open and facilitate discectomy | These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03. lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03. lot 5919006 is a 10 mm Strut. | accessdata.fda.gov |
| December 29, 2016 | 76182 | Class II | Terminated | Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head. | There is the possibility that the radial stem may loosen post-operatively at the stem bone interface. | accessdata.fda.gov |
| November 29, 2016 | 75828 | Class II | Terminated | Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument | The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack. | accessdata.fda.gov |
| November 1, 2016 | 75694 | Class II | Terminated | Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit. | accessdata.fda.gov |
| October 31, 2016 | 75580 | Class II | Terminated | Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems. | Non-conforming material used. | accessdata.fda.gov |
| October 3, 2016 | 75502 | Class II | Terminated | 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | accessdata.fda.gov |
| June 28, 2016 | 74719 | Class II | Terminated | Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium L | It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive. | accessdata.fda.gov |
| June 7, 2016 | 74415 | Class II | Terminated | Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03., Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792 | DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the TFNA aiming arm properly, which may cause surgical delay. | accessdata.fda.gov |
| May 31, 2016 | 74418 | Class II | Terminated | Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue | DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard. | accessdata.fda.gov |
| May 31, 2016 | 74416 | Class II | Terminated | Screwdriver Blade, Handle, Drill Bit, Part # Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard. | accessdata.fda.gov |
| May 23, 2016 | 74419 | Class II | Terminated | TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, in | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate. | accessdata.fda.gov |
| May 11, 2016 | 74172 | Class II | Terminated | Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. | DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size | accessdata.fda.gov |
| May 2, 2016 | 74082 | Class II | Terminated | LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones. | Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur. | accessdata.fda.gov |
| May 2, 2016 | 74080 | Class II | Terminated | DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43 | Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing. | accessdata.fda.gov |
| May 2, 2016 | 74053 | Class II | Terminated | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstru | Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. | accessdata.fda.gov |
| April 18, 2016 | 73945 | Class II | Terminated | 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part num | The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier. | accessdata.fda.gov |
| April 4, 2016 | 73770 | Class II | Terminated | 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones. | This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date. | accessdata.fda.gov |
| February 23, 2016 | 73561 | Class II | Terminated | Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers:, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofa | Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized. | accessdata.fda.gov |
| February 18, 2016 | 73552 | Class II | Terminated | Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degene | The label on the outer packaging does not match the product inside and intended use of the device. | accessdata.fda.gov |
| February 16, 2016 | 74283 | Class II | Terminated | 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slippe | Labeling does not match the cleared indications for use in the United States and Canada. | accessdata.fda.gov |
| February 16, 2016 | 73600 | Class II | Terminated | Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument | DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depr | accessdata.fda.gov |
| January 6, 2016 | 73549 | Class II | Terminated | Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879 | DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of (4mm Cortex Standard S | accessdata.fda.gov |
| December 8, 2015 | 73559 | Class II | Terminated | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dur | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is int | accessdata.fda.gov |
| December 1, 2015 | 72774 | Class II | Terminated | SYNTHES; 13.5MM Medullary Reamer Head; NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures. | The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm. | accessdata.fda.gov |
| November 2, 2015 | 72555 | Class II | Terminated | Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of f | TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing adv | accessdata.fda.gov |
| November 2, 2015 | 72553 | Class II | Terminated | 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System). | accessdata.fda.gov |
| October 19, 2015 | 72469 | Class II | Terminated | Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusio | Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchan | accessdata.fda.gov |
| October 8, 2015 | 72407 | Class II | Terminated | Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant. | The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates. Synthes determined that the product in the SNTRP module is being used in spine surgeries, which are a contraindicated use. | accessdata.fda.gov |
| October 7, 2015 | 72360 | Class II | Terminated | Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for u | The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate. | accessdata.fda.gov |
| October 6, 2015 | 72345 | Class II | Terminated | 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small | Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. | accessdata.fda.gov |
| September 28, 2015 | 72330 | Class II | Terminated | Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow S | The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S | accessdata.fda.gov |
| September 21, 2015 | 72243 | Class II | Terminated | Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion. | Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument. | accessdata.fda.gov |
| September 14, 2015 | 72238 | Class II | Terminated | Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates | Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03., 03., 03. and 03.) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended. | accessdata.fda.gov |
| September 4, 2015 | 72134 | Class II | Terminated | 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; | This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened). | accessdata.fda.gov |
| September 3, 2015 | 72133 | Class II | Terminated | Inserter for Titanium Elastic Nails (TEN), orthopedic device | potential for mechanical failures such as breakage. | accessdata.fda.gov |
| August 31, 2015 | 72139 | Class II | Terminated | Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. | The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe. | accessdata.fda.gov |
| August 11, 2015 | 71976 | Class II | Terminated | Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and | DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head. | accessdata.fda.gov |
| July 29, 2015 | 71876 | Class II | Terminated | Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large); (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional. One serious injury reported. | accessdata.fda.gov |
| July 29, 2015 | 71869 | Class II | Terminated | Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set. | Potential for micropores to form, allowing fluid to enter the hollow handle. | accessdata.fda.gov |
| July 29, 2015 | 71862 | Class II | Terminated | VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to | The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to rib sleeve breakage, and may require surgury to exchange components. Effects may also include pain, loss of deformity correction, and/or soft tissue/visceral injury | accessdata.fda.gov |
| July 22, 2015 | 71834 | Class II | Terminated | Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusio | The end cap may loosen and detach making the instrument non-functional. No injuries reported. | accessdata.fda.gov |
| July 1, 2015 | 71729 | Class II | Terminated | 8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in | The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported. | accessdata.fda.gov |
| July 1, 2015 | 71713 | Class II | Terminated | Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, U | The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item. | accessdata.fda.gov |
| June 24, 2015 | 71599 | Class II | Terminated | 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument. | It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade. | accessdata.fda.gov |
| June 24, 2015 | 71595 | Class II | Terminated | Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selectiv | The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation. | accessdata.fda.gov |
| June 10, 2015 | 71492 | Class II | Terminated | Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical i | The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.). | accessdata.fda.gov |
| November 6, 2014 | 69753 | Class II | Terminated | Synthes Small Electric Drive (SED), part number: 05.: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, r | The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infecti | accessdata.fda.gov |
| October 23, 2014 | 69603 | Class I | Terminated | Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), poste | Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification. | accessdata.fda.gov |
| October 14, 2013 | 66581 | Class II | Terminated | Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal t | Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar. | accessdata.fda.gov |
| July 30, 2013 | 66413 | Class II | Terminated | Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand. | A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. | accessdata.fda.gov |
| May 31, 2013 | 65556 | Class II | Terminated | Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies | The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locki | accessdata.fda.gov |
| May 31, 2012 | 62324 | Class II | Terminated | Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolate | USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number (Lamina Hook, Medium, right). | accessdata.fda.gov |
| September 29, 2011 | 60051 | Not yet classified | Terminated | SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler. | A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final | accessdata.fda.gov |
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Updated September 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.