Synthes (USA) Products LLC: Medical Device Recall in 2025 - (Recall #: Z-0229-2026)
See the recall detail below. You can also see other recalls from the same firm in 2025.
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
Class II
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 Code: 04.045.342TS. GTIN: 10886982301390. Lot Number: 31756P9. Expiration Date: 08/31/2025
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.
Voluntary: Firm initiated
