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.
- Company
- Synthes (Usa) Products Llc
- Recall Initiated
- September 26, 2025
- Posted
- October 21, 2025
- Recall Number
- Z-0229-2026
- Quantity
- 122 units
- Firm Location
- West Chester, PA
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.
Distribution
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.
Lot / Code Info
Product Code: 04.045.342TS. GTIN: 10886982301390. Lot Number: 31756P9. Expiration Date: 08/31/2025
Root Cause
Process control
Action Taken
DePuy Synthes notified consignees via email and mailed letter on 09/26/2025. Consignees were instructed to examine inventory and quarantine affected units, arrange for the return of any affected units, complete and return the Business Response Form, and place the notification in a visible area for awareness. If units were further distributed within your facility or to customers, please notify those customers and personnel.