BEUDAMED
    FDA Enforcement Class II Terminated

    The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures.

    Recall: Z-1715-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1715-2014
    Event ID
    68261
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    June 11, 2014
    Initiation Date
    May 13, 2014
    Classification Date
    June 4, 2014
    Termination Date
    September 15, 2014
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures.

    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

    Code Info

    Stryker Product Number: 7700-800-000 Stryker Serial Numbers: 15097, 15098, 15099, 15102, 15103, 15104, 15105, 15106, 15107, 15109, 15110, 15111, 15112, 15113, 15114, 15115, 15116, 15117, 15118

    Distribution

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

    Quantity

    20