Every recall we track for Synthes (USA) Products LLC — 74 in all — plus the complaints and injury reports the public filed about them.
Synthes recalls 2.4V TAP CORTEX SCREWS with incorrect threads that could cause improper bone fixation during surgery. Affected items have specific part numbers and lot numbers.
Synthes recalls 2.4V Tap Locking Screw Taps with incorrect threads that may cause improper fitting. Affected lots 68900P9 and 68982P8 need replacement to prevent damage.
Synthes recalls low-profile locking screws with incorrect length labeling on packaging. 42mm screws labeled as 46mm and vice versa. This could cause improper fitting in medical procedures. Affected units sold from 2023-08-31.
Synthes recalls LOW PROF LCKNG SCREW (Product Code 04.045.346TS) due to incorrect length labeling on packaging. 42mm screws labeled as 46mm and vice versa. No immediate action needed as this is a labeling error, not a safety hazard.
Synthes recalls Stardrive screwdrivers without a 5-degree relief cut that may not engage with 1.3mm/1.5mm screws, causing surgical delays. Affected units include specific lot numbers for orthopedic surgery tools.
Synthes recalls TFNA Femoral Nails 11mm, right, 130°, L 2:35mm for unconfirmed sterility. Products not properly sterilized may cause infections during surgery.
Synthes recalls sterile RIA tube assemblies (min 520mm) for bone surgery use due to unconfirmed sterility. Products may cause infection if used without proper sterilization.
Synthes recalls 2.5mm drill bits that may not be sterilized, risking infection during surgery. Affected items have specific product codes and lot numbers.
Synthes recalls VA-LCP Clavicle Plate 2.7 (part 02.112.621S) due to unconfirmed sterility. This could lead to infections if used in bone fractures. Affected units have specific part numbers and lot codes.
Synthes recalls 1.5mm drill bits with part number 310.15S due to unconfirmed sterility. These surgical accessories may cause infections if used without proper sterilization.
Synthes recalls TFNA Femoral Nails 9mm right 130° L 235mm that may not be sterilized, risking infection. Affected units have specific part and lot numbers. Contact Synthes for details.
Synthes recalls 13mm titanium hindfoot arthrodesis nails due to unconfirmed sterility. Products may cause infection if used in surgery without proper sterilization.
Synthes recalls RAPIDSORB IPS Battery Packs for non-load bearing fracture repair due to unconfirmed sterility. Products may cause infection if used without proper sterilization.
Synthes recalls unsterilized Opal spinal implants (part 08.803.231S) due to sterility risks. Affected units may cause infection or complications if used without proper sterilization.
Synthes recalls TFN-Advanced Femoral Nails with incorrect length labels that could lead to improper surgical fixation. Affected items have labels stating 170mm but measure 200mm or vice versa.
Synthes recalls TFN-Advanced Femoral Nails with incorrect length labeling that could lead to improper surgical fixation. Affected units were sold with labels indicating 170mm but measuring 200mm or vice versa.
Synthes recalls TFN-Advanced Femoral Nails with incorrect length labels that could lead to improper surgical fixation. Affected units were sold between 2020-2022.
Synthes recalls SPEED 15X12X12mm implants due to incorrect drill guide causing potential bone damage. Affected units have specific product numbers and dates.
Synthes recalls SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit (Product No. SE-2020-10) due to incorrect drill guide size that may cause improper bone preparation and damage. Affected users should contact Synthes for details.
DePuy Synthes recalls specific hammertoe implants due to incorrect drill guide causing potential bone damage. Affected products have Product No. 46.239.001 and UDI-DI 00810633022047.
Synthes recalls SPEED 9X10X10mm Continuous Compression Implant (Product No. SE-0910) due to incorrect drill guide causing potential bone damage during surgery. Affected units sold with specific lot numbers.
Synthes recalls Hammertoe CCI Kit (part 46.239.001) due to drill pin incompatibility with template causing surgical delays or soft tissue damage. Affected units sold with lot numbers MHC220119/MHC220120.
Synthes recalls radial head replacement implants due to infection and sepsis risks. All models with specific serial numbers are affected.
Synthes recalls Universal Chuck instrument handles used in orthopedic surgery due to risk of top cap detaching if jammed, causing surgical delays or infection.
DePuy Synthes recalls 14.0MM RIA 2 reamer heads due to breakage risk when surgical techniques aren't followed, potentially causing tissue damage. Affected units have part code 03.404.024S and UDI 10886982274069.
DePuy Synthes recalls 18.0MM RIA 2 reamer heads due to breakage risk when surgical techniques aren't followed, potentially causing tissue damage. Affected items have specific part code and lot numbers.
DePuy Synthes recalls 17.0MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage.
DePuy Synthes recalls 17.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage. Affected units include specific part code and lots.
DePuy Synthes recalls 15.5mm reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage.
DePuy Synthes recalls 13.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage. Affected units include all lots with specific part code.
DePuy Synthes recalls 10.0MM RIA 2 reamer heads due to breakage risk when surgical techniques aren't followed, potentially causing tissue damage. Affected items have part code 03.404.016S and all lots.
DePuy Synthes recalls 10.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage.
DePuy Synthes recalls 11.0MM RIA 2 reamer heads due to breakage risk when surgical techniques aren't followed, potentially causing tissue damage. Affected items have part code 03.404.018S and UDI 10886982273963.
DePuy Synthes recalls 14.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage.
DePuy Synthes recalls 12.5mm reamer heads for RIA 2 surgical use due to breakage risk causing soft tissue damage if improper techniques are used. Affected units have specific part code and lot numbers.
DePuy Synthes recalls 16.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage.
DePuy Synthes recalls 16.0MM reamer heads for RIA 2 surgical use due to breakage risk when improper techniques are used, potentially causing tissue damage.
DePuy Synthes recalls 13.0MM RIA 2 reamer heads for potential breakage during surgery, causing tissue damage if improper techniques are used. Affected units include specific part code and all lots.
DePuy Synthes recalls 15.0MM reamer heads for RIA 2 surgical use due to breakage risk when improper techniques are applied, potentially causing tissue damage.
DePuy Synthes recalls 11.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage.
DePuy Synthes recalls 12.0MM reamer heads for RIA 2 surgical use due to breakage risk when improper techniques are applied, potentially causing tissue damage.
DePuy Synthes SYNMESH 10mm diameter 18mm height titanium mesh for spinal implants has incorrect labeling as a general medical device instead of specially controlled medical device. This may affect regulatory compliance but does not pose immediate safety risks.
Synthes recalls Standard Ring 22mm x 28mm (TI) implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This may affect spinal surgery safety.
Synthes recalls specific end rings for spinal surgery due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects certain lot numbers of the 22mm x 28mm lateral/anterior implants used in spinal fusion procedures.
Synthes recalls END RING 17mm x 22mm spinal implants (product #495.392) due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units include specific lot numbers.
Synthes recalls END RING 12MM DIA/0 DEG (TI) product due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units include specific lot numbers for spinal implants.
Synthes recalls SYNMESH 17mm x 2:22mm 88mm height implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects specific lot numbers for spinal surgery implants.
Synthes recalls END RING 10MM DIA/0 DEG (TI) product due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units include specific lot numbers for cervical, thoracic, and lumbar spine implants.
Synthes recalls SYNMESH 15mm diameter 88mm height titanium vertebral implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This may affect safety compliance.
Synthes recalls SYNMESH 12MM DIA 88MM HEIGHT implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects patients with spinal implants.
Synthes recalls 3.0MM locking screw implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This may affect spinal surgery safety.
Synthes recalls END RING 15MM DIA/0 DEG (TI) product 495.386 due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units include specific lot numbers for cervical, thoracic, and lumbar spine implants.
Synthes recalls STANDARD RING 17MM X 22MM (TI) implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This may affect spinal surgery safety.
Synthes recalls SYNMESH 22mm x 28mm 88mm height implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects spinal surgery implants sold in the US.
Synthes recalls END RING 22mm x 28mm spinal implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects specific lot numbers for cervical, thoracic, and lumbar spine procedures.
Synthes recalls END RING 17mm x 22mm spinal implants due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units have specific product numbers and lot numbers.
Synthes recalls LCP One-Third Tubular Plates with potential reduced screw locking strength due to dimensional tolerance issues. Affected plates may not hold securely in fractures.
Synthes recalls 3.5mm spinal screws that measure 4.0mm instead of 3.5mm. This size error could cause improper spinal fusion. Affected products include Part No. 04.615.026 sold under 10L2702.
Synthes recalls trial spacers with T-handle that were modified outside approved manufacturing. These devices may not function as intended due to improper production.
Synthes recalls 3.0mm headless compression screws with incorrect thread length (4mm instead of 6mm) that may not fit properly in medical implants.
