BEUDAMED
    FDA Enforcement Class II Terminated

    BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.

    Recall: Z-1234-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1234-2016
    Event ID
    73337
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    February 22, 2016
    Classification Date
    March 23, 2016
    Termination Date
    June 15, 2016
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    Description

    BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.

    Reason

    Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.

    Code Info

    The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.

    Distribution

    US Distribution to states of: FL, NJ, AZ, and NC.

    Quantity

    4