BEUDAMED
    FDA Recall Terminated

    Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000.

    Recall: Z-0531-06 · Initiated November 8, 2005

    Recall

    Recall Number
    Z-0531-06
    Event Number
    34018
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JDB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 8, 2005
    Posted
    February 16, 2006
    Terminated
    June 16, 2006
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000.

    Reason

    The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.

    Action

    Consignees were notified via letter dated 11/10/05 and asked to return product.

    Distribution

    Nationwide, Argentina, Ireland, New Zealand and Spain.