BEUDAMED
    FDA Recall Terminated

    Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Corporate DriveMahway, NJ 07430

    Recall: Z-1261-2007 · Initiated March 13, 2006

    Recall

    Recall Number
    Z-1261-2007
    Event Number
    38815
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 13, 2006
    Posted
    September 26, 2007
    Terminated
    January 18, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Corporate DriveMahway, NJ 07430

    Reason

    Dimensional anomaly

    Action

    Recall Notification letters were sent on March 13, 2006 to all hospitals, branches/agencies via Federal Express.

    Distribution

    Worldwide -USA, Romania, Chile and Brazil.

    Quantity

    1,220 units