Recall Z-1914-2025 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker GmbH
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
| Date | Jun 6, 2025 (initiated May 28, 2025) |
| Status | Open, Classified |
| Reason | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. |
| Root cause | Process design |
| Action | Stryker notified consignees on about 05/28/2025 via FedEx letter. Consignees were instructed to review inventory and immediately quarantine any affected units on hand, and complete and return the Business Reply Form documenting receipt and product segregation. Upon receipt of the response form, Stryker will contact consignees to arrange for return of the affected units. If affected products have been further distributed, consignees were instructed to notify those customers and let Stryker know. |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System Stryker GmbH, Feb 11, 2022 |