Stryker GmbH recalls Femoral Nail
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number:1850-0830SGTIN 04546540646293.Catalog # NumberAffected lotK09F126
What the firm is doing
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.
DistributionShow detailsHide
Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1939-2025
- FDA 510(k) clearance · K101438The device's official FDA premarket clearance record
- FDA device classification · HSBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3020The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Stryker GmbHSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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