← Every firm
Synthes (USA) Products LLC FDA Recalls
24 recalls on file across devices, 0 of them Class I and 24 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.Class IIFeb 25, 2026A full lot swap between VOLT Locking Screw Tap 03.424.124 lo |
| 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.Class IIFeb 25, 2026A full lot swap between VOLT Locking Screw Tap 03.424.124 lo |
| LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM RetClass IISep 26, 2025Although the etched length on the screw is correct, the leng |
| LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM RetClass IISep 26, 2025Although the etched length on the screw is correct, the leng |
| STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants durClass IIApr 25, 2024Stardrive Screwdrivers manufactured without a 5-degree relie |
| RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures oClass IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621SClass IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear thClass IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15SClass IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.Class IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231Class IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis Class IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fracturClass IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractuClass IIJan 24, 2024Products not sterilized, sterility cannot be confirmed |
| TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization Class IIFeb 1, 2023TFNA Femoral Nails labeled and etched as 200mm may measure 1 |
| TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization Class IIFeb 1, 2023TFNA Femoral Nails labeled and etched as 200mm may measure 1 |
| TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization Class IIFeb 1, 2023TFNA Femoral Nails labeled and etched as 200mm may measure 1 |
| SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512Class IISep 27, 2022The subject products are being recalled because they contain |
| DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001Class IISep 27, 2022The subject products are being recalled because they contain |
| SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910Class IISep 27, 2022The subject products are being recalled because they contain |
| SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT ContinuousClass IISep 27, 2022The subject products are being recalled because they contain |
| Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001Class IIAug 30, 2022Drill Pin (drill bit) is not compatible with the Drill Templ |
| Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in Class IIApr 7, 2022DePuy Synthes Radial Head Replacement System Contraindicatio |
| Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in tClass IIDec 22, 2021Top cap may loosen and detach if the Universal Chuck becomes |