BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1514-2018 · Initiated March 19, 2018

    Recall

    Recall Number
    Z-1514-2018
    Event Number
    79698
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    HWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 19, 2018
    Terminated
    April 11, 2019
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    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.

    Action

    The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTICE" dated 3/19/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to the following: Review the instructions listed in this notification. Forward this notice to anyone in your facility that needs to be informed. If any of the affected product has been forwarded to another facility, contact that facility. Keep a copy of this notice. Return the Verification Section (page 3 of this letter) to Synthes by: o Fax: 1-888-731-7954 or o Scan/email: [email protected] . Follow the Instructions if connecting screw for the stem extractor breaks If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

    Distribution

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

    Quantity

    31