BEUDAMED
    FDA Enforcement Class II Ongoing

    DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

    Recall: Z-1257-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1257-2022
    Event ID
    90230
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2022
    Initiation Date
    May 5, 2022
    Classification Date
    June 9, 2022
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

    Reason

    A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.

    Code Info

    Lot number 078T1141

    Distribution

    U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.

    Quantity

    20