BEUDAMED
    FDA Recall Terminated

    Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive; Mahwah, NJ 07430 Authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan Cedex, France

    Recall: Z-1778-2008 · Initiated April 15, 2005

    Recall

    Recall Number
    Z-1778-2008
    Event Number
    47829
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 15, 2005
    Posted
    August 27, 2008
    Terminated
    September 24, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive; Mahwah, NJ 07430 Authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan Cedex, France

    Reason

    The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.

    Action

    An IMPORTANT MARKET WITHDRAWAL letter was issued on April 19, 2005 and sent Federal Express to those consignees who received the device. The letter instructed them to examine their inventory to identify instruments, reconcile these instruments on an attached accountability form; fax a copy of this form within 2 days of receipt of the letter; retrieve and return affected product; contact Stryker Customer Service to re-order.

    Distribution

    Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.

    Quantity

    24 total