BEUDAMED
    FDA Recall Terminated

    EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

    Recall: Z-0328-2018 · Initiated December 12, 2017

    Recall

    Recall Number
    Z-0328-2018
    Event Number
    78727
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 12, 2017
    Terminated
    June 13, 2022
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

    Reason

    The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.

    Action

    The field safety notice was disseminated by email on 12/12/2017. The notice stated the following: "DJO Sales Agents Action: Please review the bulletin that is provided with this notice. This bulletin contains new instructions on the use of the Locking Punch Guide and Punch. Please ensure your surgeons are familiar with this information. DJO Surgical then requires that you complete the attached acknowledgment and email it to [email protected]. Please have this form returned by December 15, 2017 Once redesigned guides are available, they will be exchanged through a separate field action."

    Distribution

    One medical device distributor in California.

    Quantity

    2 units