BEUDAMED
    FDA Enforcement Class II Ongoing

    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980

    Recall: Z-2103-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2103-2021
    Event ID
    87942
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 28, 2021
    Initiation Date
    May 12, 2021
    Classification Date
    July 20, 2021
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980

    Reason

    Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.

    Code Info

    Lot # 115T1035

    Distribution

    US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None

    Quantity

    10 units