GAMMA recallZ-1914-2025 · Stryker GmbH · initiated May 28, 2025
Open, Classified
Is my device affected?
- 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.
- 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.
- 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 confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
FDA root cause category: Process design
What the company is doing
Stryker notified consignees on about 05/28/2025 via FedEx letter. Consignees were instructed to review inventory and immediately quarantine any affected units on hand, and complete and return the Business Reply Form documenting receipt and product segregation. Upon receipt of the response form, Stryker will contact consignees to arrange for return of the affected units. If affected products have been further distributed, consignees were instructed to notify those customers and let Stryker know.
Recall details
- Recall number
- Z-1914-2025
- Status
- Open, Classified
- Initiated by the company
- May 28, 2025
- Posted by the FDA
- Jun 6, 2025
- Recalling firm
- Stryker GmbH
- Product code
- HSB
- FDA submissions
- K213328
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Product description
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Code information (models, lots, serial numbers)
Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GAMMA 8425-0320SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall3 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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