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U.S. Department of Health and Human Services

Class 2 Device Recall T2 Greater Trochanter Nail

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 Class 2 Device Recall T2 Greater Trochanter Nailsee related information
Date Initiated by FirmMay 22, 2025
Date PostedJune 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1939-2025
Recall Event ID 96924
510(K)NumberK101438 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductFemoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Code Information Catalog Number: 1850-0830S. GTIN: 04546540646293. Batch lot number: K09F126
FEI Number 3002807830
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker 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 in Commerce1
DistributionWorldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HSB
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