BEUDAMED
    FDA Enforcement Class II Terminated

    AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.

    Recall: Z-0117-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0117-2021
    Event ID
    86395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 28, 2020
    Initiation Date
    August 31, 2020
    Classification Date
    October 16, 2020
    Termination Date
    April 19, 2024
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.

    Reason

    Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.

    Code Info

    Lot Number: 964W1000

    Distribution

    US Nationwide distribution.

    Quantity

    15