FDA Device recall Z-1914-2025
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System by Stryker, citing investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1914-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-28 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker |
| Distribution | US |
Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Reason
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Identifiers
| code_info | Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1914-2025%22
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