Device product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Z-1914-2025
Product summary
- Firm
- Stryker GmbH
- Event
- Event 96927
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1914-2025
Official wording
Reason: Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Code information: Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Derived failure modes
-
Unknown
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.