Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
FDA device recall Z-1914-2025 · posted 2025-06-06 · Open, Classified
Recall details
- Recalling firm
- Stryker GmbH
- Reason for recall
- Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- HSB
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
- Date initiated
- 2025-05-28
- Date posted
- 2025-06-06
- Location
- Selzach, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (K213328) | Stryker GmbH | 2022-02-11 |