BEUDAMED
    FDA Recall Terminated

    Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

    Recall: Z-0001-2012 · Initiated January 20, 2011

    Recall

    Recall Number
    Z-0001-2012
    Event Number
    57858
    Firm
    Medtronic Navigation, Inc
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 20, 2011
    Posted
    October 3, 2011
    Terminated
    October 3, 2011
    Address
    826 Coal Creek Circle, Louisville, CO, 80027-9710

    Description

    Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

    Reason

    Distal end of tactile probe may break off during use.

    Action

    Medtronic sent an "Urgent Product Safety Notice" to all affected customers dated Jan 20, 2011. The letter included affected product and updated instructions for use. On-site training was given for the use of the probes by Medtronic Representatives. For information on this recall call Medtronics at (720) 890-3409.

    Distribution

    Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea

    Quantity

    6 probes