Synthes (USA) Products LLC: Device Recall
Recall #Z-0228-2026 · 09/26/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0228-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Synthes (USA) Products LLC
- Status
- Ongoing
- Date Initiated
- 09/26/2025
- Location
- West Chester, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 units
Reason for Recall
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.
Product Description
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.
Other Recalls by Synthes (USA) Products LLC
- Class II: Risk 09/26/2025
- Class II: Risk 04/25/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.