BEUDAMED
    FDA Recall Terminated

    Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.

    Recall: Z-0991-05 · Initiated June 20, 2005

    Recall

    Recall Number
    Z-0991-05
    Event Number
    32511
    Firm
    Warsaw Orthopedic, Inc.
    FEI Number
    1824199
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    June 20, 2005
    Posted
    July 13, 2005
    Terminated
    February 8, 2006
    Address
    2500 Silveus Xing, Warsaw, IN, 46582-8598

    Description

    Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.

    Reason

    The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.

    Action

    Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.

    Distribution

    Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.