BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0258-2024 · Initiated September 29, 2023

    Recall

    Recall Number
    Z-0258-2024
    Event Number
    93214
    FEI Number
    1000116912
    Product Code
    MBH
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    September 29, 2023
    Posted
    November 7, 2023
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    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.

    Action

    On 9/29/23, recall notices were emailed to customers who were asked to do the following: 1) Knee punch handles should be visually inspected prior to use for any damage. Upon completion of surgery, visually inspect and verify there is no breakage. The attached quality bulletin provides guidance on an acceptable and unacceptable device. 2) Contact your customer service rep at [email protected] to report failures or to request replacements. 3) Complete and return the response form that asks customers to check all related devices in inventory and report the number of related devices in inventory. Questions can be directed to [email protected]

    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