Device product
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Z-1939-2025
Product summary
- Firm
- Stryker GmbH
- Event
- Event 96924
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1939-2025
Official wording
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 information: Catalog Number: 1850-0830S. GTIN: 04546540646293. Batch lot number: K09F126
Distribution pattern: Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Derived failure modes
-
Labeling or packaging
labeled as left version but contained