BEUDAMED
    FDA Enforcement Class II Terminated

    Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.

    Recall: Z-1514-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1514-2018
    Event ID
    79698
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    March 19, 2018
    Classification Date
    April 25, 2018
    Termination Date
    April 11, 2019
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.

    Reason

    There is a potential for the connection screw of the stem extractor to break.

    Code Info

    09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949

    Distribution

    Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.

    Quantity

    31