BEUDAMED
    FDA Enforcement Class II Ongoing

    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

    Recall: Z-1384-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1384-2023
    Event ID
    91906
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2023
    Initiation Date
    February 28, 2023
    Classification Date
    April 12, 2023
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

    Reason

    Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.

    Code Info

    REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03

    Distribution

    US: TX, IN, MD, CA, KS, AL, HI, WA

    Quantity

    29