Long Nail — Class II medical device recall Z-1914-2025
Ongoing recall by Stryker GmbH, reported 2025-06-18, distributed nationwide. Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
| Recall number | Z-1914-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, Switzerland |
| Recall initiated | 2025-05-28 |
| Classified | 2025-06-06 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, JP |
| UPC / GTIN / UDI-DI | 07613327479515 |
| Lot numbers | K1BC9B7 |
| Model numbers | 84250320S |
Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Reason for recall
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1914-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.