Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
- Recall Initiated
- May 28, 2025
- Posted
- June 6, 2025
- Recall Number
- Z-1914-2025
Reason for Recall
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Distribution
Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Lot / Code Info
Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Root 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.