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Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number:… recallZ-1939-2025 · Stryker GmbH · initiated May 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company 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.

Recall details

Recall number
Z-1939-2025
Status
Open, Classified
Initiated by the company
May 22, 2025
Posted by the FDA
Jun 10, 2025
Recalling firm
Stryker GmbH
Quantity
1
Product code
HSB
FDA submissions
K101438
Distribution
Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.

Product description

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

Code information (models, lots, serial numbers)

Catalog Number: 1850-0830S. GTIN: 04546540646293. Batch lot number: K09F126

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96924).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page