Recall Z-1939-2025 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker GmbH
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
| Date | Jun 10, 2025 (initiated May 22, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 1 |
| Distribution | Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101438 | T2 GREATER TROCHANTER NAIL Howmedica Osteonics Corp., Jun 17, 2010 |