Recall Z-1940-2025— Stryker GmbH

Name: FDA recall Z-1940-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-22

Class II · Ongoing

Class II FDA medical device recall by Stryker GmbH, initiated 2025-05-22. It names one FDA 510(k) clearance: K101438. Product: 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..

Recalling firm: Stryker GmbH
Classification: Class II
Status: Ongoing
Initiated: 2025-05-22
Firm location: Selzach, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K101438 — T2 GREATER TROCHANTER NAILHowmedica Osteonics Corp.·cleared 2010-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.