BEUDAMED
    FDA Recall Terminated

    DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, sterile, DePuy International, Ltd, Leeds, United Kingdom.

    Recall: Z-2048-2010 · Initiated March 5, 2010

    Recall

    Recall Number
    Z-2048-2010
    Event Number
    55575
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    KWA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 5, 2010
    Posted
    July 17, 2010
    Terminated
    May 10, 2012
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, sterile, DePuy International, Ltd, Leeds, United Kingdom.

    Reason

    Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-m

    Action

    DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.

    Distribution

    Nationwide

    Quantity

    194