BEUDAMED
    FDA Recall Terminated

    Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.

    Recall: Z-0825-2015 · Initiated November 7, 2014

    Recall

    Recall Number
    Z-0825-2015
    Event Number
    69984
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 7, 2014
    Posted
    December 17, 2014
    Terminated
    March 24, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.

    Reason

    Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the

    Action

    On 11/7/2014, URGENT INFORMATION - RECALL NOTICE notifications were sent to the affected distributors, hospitals, and doctors with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospitals and doctors were notified via sales consultant visit. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). For questions about device recall information provided, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).

    Distribution

    Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.

    Quantity

    19 units worldwide