Synthes (USA) Products recalls
9 official recalls and safety alerts involving Synthes (USA) Products since 2022-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Synthes (USA) Products or the relevant agency.
- 2026-04-08
USSynthes (USA) Products LLC recalls 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
FDA · DeviceSynthes (USA) Products LLCUS Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD,…Official notice →- 2025-10-29
- US
Synthes (USA) Products LLC recalls LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral…
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…
FDA · DeviceSynthes (USA) Products LLCWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL,…Official notice → - 2024-06-05
- US
Synthes (USA) Products LLC recalls STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during…
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
FDA · DeviceSynthes (USA) Products LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2024-03-13
- US
Synthes (USA) Products LLC recalls Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Products not sterilized, sterility cannot be confirmed
FDA · DeviceSynthes (USA) Products LLCWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2023-03-22
- US
Synthes (USA) Products LLC recalls TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur…
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
FDA · DeviceSynthes (USA) Products LLCWorldwide - US Nationwide distribution in the states of MS, OR, TX and the…Official notice → - 2022-10-26
- US
Synthes (USA) Products LLC recalls SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
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…
- 2022-10-12
- US
Synthes (USA) Products LLC recalls Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
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…
- 2022-05-18
- US
Synthes (USA) Products LLC recalls Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of…
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
- 2022-02-16
- US
Synthes (USA) Products LLC recalls Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the…
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…