BEUDAMED
    FDA Recall Terminated

    Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.

    Recall: Z-1605-2010 · Initiated April 7, 2010

    Recall

    Recall Number
    Z-1605-2010
    Event Number
    55498
    Firm
    Stryker Communications Corp
    FEI Number
    3002975342
    Product Code
    BRY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 7, 2010
    Posted
    May 14, 2010
    Terminated
    March 30, 2011
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.

    Reason

    Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.

    Action

    An Urgent: Medical Device Recall letter dated April 19, 2010 was sent to customers. It was recommended that customers continue use of the product unless the monitor becomes unlevel. The customer was notified that a Stryker Representative would contact their facility to coordinate a service call to inspect the affected units. Questions are directed to the firm via phone at 972-410-7617 or via email at .

    Distribution

    Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) .

    Quantity

    1498