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…
Read the official notice →- Date
- 2025-10-29
- Country
- United States
- Brand
- Synthes (USA) Products
- Product
- LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Synthes (USA) Products recalls
- 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 →- 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…
Other drugs & medical recalls in the United States
- 2025-10-29
- US
Tandem Diabetes Care, Inc. recalls t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide…
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an…
FDA · DeviceTandem Diabetes Care, Inc.US nationwide distribution including Puerto Rico.Official notice → - US
GE Medical Systems, LLC recalls MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001,…
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires.…
FDA · DeviceGE Medical Systems, LLCWorldwide Distribution: US (nationwide) and OUS (foreign/Global) to countries…Official notice → - US
CPM Medical Consultants, LLC. recalls Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L,…
Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for…
FDA · DeviceCPM Medical Consultants, LLC.US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL.Official notice → - US
Theken Companies LLC recalls iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head…
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
FDA · DeviceTheken Companies LLCUS Nationwide distribution in the states of NJ, PA, and TX.Official notice → - US
Home Health US, Incorporated recalls One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is…
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
FDA · DeviceHome Health US, IncorporatedU.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL,…Official notice → - US
UIH Technologies LLC recalls Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.