BEUDAMED
    FDA Enforcement Class II Ongoing

    DJO EMPOWR KNEE Femoral Sizer

    Recall: Z-1524-2021 · Reported May 12, 2021

    Enforcement

    Recall Number
    Z-1524-2021
    Event ID
    87332
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 12, 2021
    Initiation Date
    February 5, 2021
    Classification Date
    April 30, 2021
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    DJO EMPOWR KNEE Femoral Sizer

    Reason

    Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.

    Code Info

    Model Number: 800-05-034 Lot Number: 326336L02

    Distribution

    U.S.: FL, IN, and MN O.U.S.: None

    Quantity

    16 units