BEUDAMED
    FDA Recall Terminated

    Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 11, standard body. Cat. No. 7841-11-10.

    Recall: Z-0472-03 · Initiated January 7, 2003

    Recall

    Recall Number
    Z-0472-03
    Event Number
    25375
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 7, 2003
    Posted
    January 28, 2003
    Terminated
    February 9, 2004
    Address
    345 E. Main St., Warsaw, IN, 46580

    Description

    Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 11, standard body. Cat. No. 7841-11-10.

    Reason

    The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.

    Action

    Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.

    Distribution

    United States, Australia and Canada.