BEUDAMED
    FDA Recall Open, Classified

    stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

    Recall: Z-1138-2025 · Initiated January 8, 2025

    Recall

    Recall Number
    Z-1138-2025
    Event Number
    96098
    Firm
    Stryker Corporation
    FEI Number
    3015967359
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 8, 2025
    Posted
    February 11, 2025
    Address
    1941 Stryker Way, Portage, MI, 49002-9711

    Description

    stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

    Reason

    Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

    Action

    Stryker issued an URGENT MEDICAL DEVICE recall notice to its consignees on 01/08/2025 via FedEx. The notice explained the issue, potential risk, and requested the affected items be quarantined pending return. Stryker will issue a shipping label to the consignee once the response form has been received. Distributors were directed to forward the notice to all those to whom the affected devices were distributed.

    Distribution

    Worldwide distribution.

    Quantity

    622 units