Recall Z-1939-2025
Stryker GmbH · initiated May 22, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Codes / lots: Catalog Number: 1850-0830S. GTIN: 04546540646293. Batch lot number: K09F126
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
Stryker notified consignees on about 05/22/2025 via letter. Consignees were instructed to immediately check their inventory for affected units and quarantine any on hand, and complete and return the Business Reply Form by email to . Upon receipt of the completed Business Reply Form, Stryker will contact customers to arrange for the return of their product(s). If consignees have further distributed the product, they were instructed to notify their customers.
Details
- Recall number
- Z-1939-2025
- Initiated
- May 22, 2025
- Posted by FDA
- June 10, 2025
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 1
- Distribution
- Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
- Recalling firm
- Stryker GmbH, Selzach
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1940-2025 Class II | Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version… | 05/22/2025Open, Classified |