BEUDAMED
    FDA Recall Terminated

    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    Recall: Z-2053-2014 · Initiated March 17, 2014

    Recall

    Recall Number
    Z-2053-2014
    Event Number
    67813
    Firm
    Stryker Communications
    FEI Number
    3002975342
    Product Code
    BRY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 17, 2014
    Posted
    July 15, 2014
    Terminated
    May 15, 2015
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    Reason

    During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.

    Action

    Direct accounts in the US were notified by letter dated March 21, 2014, and asked to report any malfunctions to Stryker Communications immediately. In addition, Stryker Representatives will visit all US accounts to inspect all the product units on hand. If needed, Representatives will check that black, screw/lock washers supplied by Stryker are secured in place and will replace any that are not the typed furnished by Stryker. All units will be updated with a yellow, warning sticker on the monitor bracket which reads: "Failure to properly install the screw and lock washer below can result in the attached component/equipment falling." Stryker Communications' foreign distributors will oversee notification, inspection, and corrections of their accounts and report corrections and other findings to Stryker Communications.

    Distribution

    Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia

    Quantity

    953 total STRYKER SHAPE Arms of all types