BEUDAMED
    FDA Recall Terminated

    Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.

    Recall: Z-1090-05 · Initiated May 27, 2005

    Recall

    Recall Number
    Z-1090-05
    Event Number
    32281
    Firm
    Warsaw Orthopedic, Inc.
    FEI Number
    1824199
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 27, 2005
    Posted
    August 6, 2005
    Terminated
    September 20, 2005
    Address
    2500 Silveus Xing, Warsaw, IN, 46582-8598

    Description

    Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.

    Reason

    The product is labeled as sterile, but this lot was not sterilized.

    Distribution

    United States and Canada.

    Quantity

    140