BEUDAMED
    FDA Enforcement Class II Ongoing

    DJO EMPOWR Knee Punch Handle, REF: 801-05-040

    Recall: Z-0258-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0258-2024
    Event ID
    93214
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2023
    Initiation Date
    September 29, 2023
    Classification Date
    November 7, 2023
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    DJO EMPOWR Knee Punch Handle, REF: 801-05-040

    Reason

    Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.

    Code Info

    UDI-DI: 00190446238881, Lots: 305197L02D, 305197L02E, 318871L10D, 318871L10E, 305197L02B, 305197L02C, 318871L10B, 318871L10C, 325045L17A, 325045L17B, 325045L17C, 305197L02, 318871L10, 325045L17, 327669L03, 331146L01, 332158L06, 334314L04, 336735L04, 336801L01, 340391L01, 341961L01, 342586L01, 346101L01, 350076L01, 351106L02, 360277L01, 366833L03, 374648L01, 380510L01

    Distribution

    US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA

    Quantity

    406