BEUDAMED
    FDA Recall Terminated

    Margron DTC Hip Replacement System; Margron hip extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-203. Product is used for Orthopedic surgery.

    Recall: Z-1995-2008 · Initiated January 11, 2008

    Recall

    Recall Number
    Z-1995-2008
    Event Number
    47369
    Firm
    Portland Orthopaedics Pty, Ltd. 1 South Street, Suite 3, Level 5 Saint George Hospital Kogarah Australia
    FEI Number
    3003755751
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 11, 2008
    Posted
    September 18, 2008
    Terminated
    November 12, 2009

    Description

    Margron DTC Hip Replacement System; Margron hip extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-203. Product is used for Orthopedic surgery.

    Reason

    Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.

    Action

    Stocks were pulled from U.S. consignees on or before 1/11/08. Consignee and implanting surgeon letters dated 6/20/08 were sent advising of the issue and recommending patient monitoring. For assistance, contact Portland Orthopaedics at 1-810-329-3348.

    Distribution

    Nationwide.

    Quantity

    2403 of all products