BEUDAMED
    FDA Enforcement Class II Terminated

    EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.

    Recall: Z-0327-2018 · Reported January 17, 2018

    Enforcement

    Recall Number
    Z-0327-2018
    Event ID
    78727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 17, 2018
    Initiation Date
    December 12, 2017
    Classification Date
    January 10, 2018
    Termination Date
    June 13, 2022
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, 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.

    Code Info

    Lot 252564

    Distribution

    One medical device distributor in California.

    Quantity

    2 units