BEUDAMED
    FDA Enforcement Class II Ongoing

    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

    Recall: Z-2603-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2603-2023
    Event ID
    92969
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 27, 2023
    Initiation Date
    August 4, 2023
    Classification Date
    September 19, 2023
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

    Reason

    Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

    Code Info

    UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029

    Distribution

    US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany

    Quantity

    20