BEUDAMED
    FDA Recall Terminated

    Distal Centralizer 10 mm

    Recall: Z-0315-2011 · Initiated July 28, 2010

    Recall

    Recall Number
    Z-0315-2011
    Event Number
    56499
    Firm
    Ortho Development Corporation
    FEI Number
    3017298928
    Product Code
    KWY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 28, 2010
    Posted
    November 3, 2010
    Terminated
    November 4, 2010
    Address
    12187 South Business Park Dr, Draper, UT, 84020

    Description

    Distal Centralizer 10 mm

    Reason

    The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.

    Action

    Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.

    Distribution

    Worldwide Distribution: Japan

    Quantity

    39 units