BEUDAMED
    FDA Recall Open, Classified

    Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

    Recall: Z-1914-2025 · Initiated May 28, 2025

    Recall

    Recall Number
    Z-1914-2025
    Event Number
    96927
    Firm
    Stryker GmbH Bohnackerweg 1 Selzach Switzerland
    FEI Number
    3002807830
    Product Code
    HSB
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    May 28, 2025
    Posted
    June 6, 2025

    Description

    Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

    Reason

    Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

    Action

    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.

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.