Device 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 Nailing (RFNA) System and the Tibial Nail Advanced System.
Z-0228-2026
Product summary
- Event
- Event 97693
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-0228-2026
Official wording
Reason: 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.
Code information: Product Code: 04.045.346TS. GTIN: 10886982301413. Lot Number: 31756P7. Expiration Date: 08/31/2025
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.
Derived failure modes
-
Unknown
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.