BEUDAMED
    FDA Recall Terminated

    Stryker Visum 300 Ceiling-mounted Exam Light.

    Recall: Z-1992-2013 · Initiated July 25, 2013

    Recall

    Recall Number
    Z-1992-2013
    Event Number
    65888
    Firm
    Stryker Communications
    FEI Number
    3002975342
    Product Code
    KZF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 25, 2013
    Posted
    August 21, 2013
    Terminated
    April 3, 2015
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    Stryker Visum 300 Ceiling-mounted Exam Light.

    Reason

    Potential incomplete final weld on the drop tube flange.

    Action

    The firm decided to recall and notified consignees with an "Urgent Medical Device Correction/Removal" notification letter dated 07/29/13. The product issue was described and recommended actions were provided. Customers may contact Stryker Technical Support at 866-841-5663.

    Distribution

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

    Quantity

    1,375 units