BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197

    Recall: Z-1148-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1148-2020
    Event ID
    84664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2020
    Initiation Date
    July 19, 2019
    Classification Date
    February 11, 2020
    Termination Date
    February 2, 2024
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400, United States

    Description

    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197

    Reason

    Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.

    Code Info

    19113AG2, 19130AG2, 19134AG2, 19115AG2, 19131AG2, 19133AG2, 19154AG2,19155AG2, 19156AG2, 19157AG2, 19149AG2.

    Distribution

    US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI

    Quantity

    87 devices