BEUDAMED
    FDA Recall Terminated

    The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).

    Recall: Z-1716-2014 · Initiated May 13, 2014

    Recall

    Recall Number
    Z-1716-2014
    Event Number
    68261
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    May 13, 2014
    Posted
    June 4, 2014
    Terminated
    September 15, 2014
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).

    Reason

    The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints

    Action

    On May 13, 2014, Stryker Instruments sent URGENT MEDICAL DEVICE RECALL notification to their consignees. Notification included the description of the affected product, reason for the recall, risk to health, and actions to be taken by the Customer/User. Once Stryker receives the response from the customer, a Stryker Representative will contact the customer to set up a time to perform the upgrade to the affected power box. Old Power Boxes will be returned to Stryker and placed in an industrial compactor/recycler for destruction. Questions regarding the recall are directed to Kelly Jo Whipple M-F 8am-5pm @ 269-389-2921 or [email protected]

    Distribution

    Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.

    Quantity

    20