FDA Enforcement
Class II
Ongoing
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Recall: Z-1940-2025
·
Reported June 18, 2025
Enforcement
- Recall Number
- Z-1940-2025
- Event ID
- 96924
- 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 22, 2025
- Classification Date
- June 10, 2025
- Address
- Bohnackerweg 1, Selzach, N/A, Switzerland
Description
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Reason
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Code Info
Catalog Number: 1851-0830S. GTIN: 04546540647184. Batch lot number: K09F17F
Distribution
Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Quantity
2