BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Visum 300 Ceiling-mounted Exam Light.

    Recall: Z-1992-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1992-2013
    Event ID
    65888
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Communications
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2013
    Initiation Date
    July 25, 2013
    Classification Date
    August 21, 2013
    Termination Date
    April 3, 2015
    Address
    1410 Lakeside Pkwy Ste 100, N/A, Flower Mound, TX, 75028-4026, United States

    Description

    Stryker Visum 300 Ceiling-mounted Exam Light.

    Reason

    Potential incomplete final weld on the drop tube flange.

    Code Info

    Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.

    Distribution

    Worldwide Distribution: US natiowide and to the country of Canada.

    Quantity

    1,375 units