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Open, Classified

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

FDA Recall Z-1939-2025 · Posted 2025-06-10

Recalling FirmStryker GmbH
Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2025-05-22
Product Quantity1

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101438T2 GREATER TROCHANTER NAILHowmedica Osteonics Corp. · 2010-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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