BEUDAMED
    FDA Enforcement Class II Terminated

    AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.

    Recall: Z-1007-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-1007-2017
    Event ID
    76060
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    December 12, 2016
    Classification Date
    January 11, 2017
    Termination Date
    May 19, 2017
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710, United States

    Description

    AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.

    Reason

    Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation¿ System with Touch N Go Pointer Probes for patient registration.

    Code Info

    lot number 150626B

    Distribution

    US Nationwide Distribution.

    Quantity

    111 devices