Recall Z-1914-2025
Stryker GmbH · initiated May 28, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Codes / lots: Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Reason for recall
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-1914-2025
- Initiated
- May 28, 2025
- Posted by FDA
- June 6, 2025
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
- Recalling firm
- Stryker GmbH, Selzach