BEUDAMED
    FDA Recall Terminated

    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100

    Recall: Z-0919-2013 · Initiated December 20, 2012

    Recall

    Recall Number
    Z-0919-2013
    Event Number
    64306
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 20, 2012
    Posted
    March 8, 2013
    Terminated
    September 30, 2015
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100

    Reason

    Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.

    Action

    Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue.

    Distribution

    Nationwide Distribution.

    Quantity

    48 units