BEUDAMED
    FDA Recall Terminated

    Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas

    Recall: Z-0213-05 · Initiated November 3, 2004

    Recall

    Recall Number
    Z-0213-05
    Event Number
    30385
    Firm
    Power Surgical Solutions
    FEI Number
    1625507
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2004
    Posted
    November 20, 2004
    Terminated
    November 3, 2005
    Address
    4620 N Beach St, Fort Worth, TX, 76137-3219

    Description

    Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas

    Reason

    Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).

    Action

    The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.

    Distribution

    Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.

    Quantity

    12,286 cases of 4 units per case