BEUDAMED
    FDA Enforcement Class II Ongoing

    Wright EVOLVE TRIAD Plate Cutter, REF 49510120

    Recall: Z-1366-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1366-2022
    Event ID
    90399
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2022
    Initiation Date
    June 14, 2022
    Classification Date
    July 11, 2022
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423, United States

    Description

    Wright EVOLVE TRIAD Plate Cutter, REF 49510120

    Reason

    The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use

    Code Info

    Lot codes: 955401, 1168853, 1349302, 1956936, 2486857

    Distribution

    Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico

    Quantity

    231