BEUDAMED
    FDA Enforcement Class II Ongoing

    DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.

    Recall: Z-0508-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0508-2024
    Event ID
    93465
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2023
    Initiation Date
    November 10, 2023
    Classification Date
    December 7, 2023
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.

    Reason

    Due to incorrect product/device within packaging.

    Code Info

    Model Number: 243-01-108 UDI-DI Code: 00190446231295 Lot Number: 277W1114 Model Number: 353-03-108 UDI-DI Code: 00190446231295 Lot Number: 213W1051

    Distribution

    US Nationwide distribution.

    Quantity

    37 devices