Recall Z-0228-2026 ยท JDS Nail, Fixation, Bone
Synthes (USA) Products LLC
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.
| Date | Oct 21, 2025 (initiated Sep 26, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 120 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm Synthes (USA) Products, LLC, Sep 3, 2020 |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm Synthes (USA) Products, LLC, Sep 23, 2020 |