Summary
The FDA issued a Class II for Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. by Stryker GmbH. 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 w.
Details
Source
Device Recall
External ID
Z-1939-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Lot/Code Info: Catalog Number: 1850-0830S. GTIN: 04546540646293. Batch lot number: K09F126
Quantity Affected: 1
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.
Distribution
Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-22
Company
Selzach
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker GmbH have FDA actions?
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1939-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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