BEUDAMED
    FDA Recall Terminated

    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

    Recall: Z-1602-2016 · Initiated April 8, 2016

    Recall

    Recall Number
    Z-1602-2016
    Event Number
    73869
    Firm
    Medtronic Sofamor Danek Usa, Inc Dallas Distribution
    FEI Number
    1625507
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 8, 2016
    Posted
    May 4, 2016
    Terminated
    February 16, 2017
    Address
    4620 N Beach St, Haltom City, TX, 76137-3219

    Description

    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

    Reason

    Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

    Action

    A notification letter was provided to each consignee, translated as necessary, on April 8, 2016.

    Distribution

    Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.

    Quantity

    81 tools