BEUDAMED
    FDA Recall Terminated

    Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant.

    Recall: Z-0535-2009 · Initiated July 10, 2008

    Recall

    Recall Number
    Z-0535-2009
    Event Number
    49112
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 10, 2008
    Posted
    January 15, 2009
    Terminated
    October 28, 2009
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant.

    Reason

    Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.

    Action

    A letter, "Urgent Device Correction" dated July 8, 2008 was sent via certified mail to implanting surgeons advising them of the issues and guidance on how to mitigate the problem. A communication was also sent to all sales representatives and territory offices on July 15, 2008. For questions, please contact Depuy Orthopaedics, Inc. Customer Service at 1-800-473-3789.

    Distribution

    Nationwide Distribution.

    Quantity

    1,521 of all devices.