BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

    Recall: Z-0005-2023 · Reported October 12, 2022

    Enforcement

    Recall Number
    Z-0005-2023
    Event ID
    90772
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2022
    Initiation Date
    August 3, 2022
    Classification Date
    October 4, 2022
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

    Reason

    The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.

    Code Info

    UDI/DI: (01)00840420185877(11)210107(17)290105 Lot Number 1704691

    Distribution

    US Nationwide distribution.

    Quantity

    16 units