BEUDAMED
    FDA Recall Terminated

    Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.

    Recall: Z-1794-2015 · Initiated May 5, 2015

    Recall

    Recall Number
    Z-1794-2015
    Event Number
    71278
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 5, 2015
    Posted
    June 12, 2015
    Terminated
    July 2, 2015
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.

    Reason

    Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.

    Action

    Medtronic sent an Medical Device Safety Alert letter dated May 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the user: "Examine your inventory and if any of the affected products are found, please quarantine them for return to Medtronic. "A Medtronic representative will follow-up to arrange for removal and replacement. If you have any questions regarding this action, please contact Medtronic Navigation Technical Services at 1-800-595-9709.

    Distribution

    US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.

    Quantity

    18