FDA Recall Open, Classified

Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.

Recall: Z-1939-2025 · Initiated May 22, 2025

Recall

Recall Number
Z-1939-2025
Event Number
96924
Firm
Stryker GmbH Bohnackerweg 1 Selzach Switzerland
FEI Number
3002807830
Product Code
HSB
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
May 22, 2025
Posted
June 10, 2025

Description

Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.

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.

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.

Distribution

Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.

Quantity

1