FDA Enforcement
Class II
Ongoing
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Recall: Z-1914-2025
·
Reported June 18, 2025
Enforcement
- Recall Number
- Z-1914-2025
- Event ID
- 96927
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 18, 2025
- Initiation Date
- May 28, 2025
- Classification Date
- June 6, 2025
- Address
- Bohnackerweg 1, Selzach, N/A, Switzerland
Description
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.
Code Info
Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Distribution
Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.