BEUDAMED
    FDA Recall Terminated

    Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. Canister holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical setting.

    Recall: Z-1569-2009 · Initiated May 19, 2009

    Recall

    Recall Number
    Z-1569-2009
    Event Number
    52099
    Firm
    Stryker Communications Corp
    FEI Number
    3002975342
    Product Code
    BRY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 19, 2009
    Posted
    July 13, 2009
    Terminated
    April 26, 2010
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. Canister holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical setting.

    Reason

    Design flaw on the E-Cylinder canister holder may result in early fatigue and failure of the bracket screws, which could cause the cage to become detached from its mount and fall.

    Action

    An "Urgent: Device Recall" letter dated May 19, 2009 was issued to customers. Customers were advised to discontinue use of all affected E-cylinder holders. Consignees were asked to return the "Product Accountability Form" included with the recall letter, after which consignees will be provided with an improved cylinder holder at no cost. Direct questions to Stryker Communications at 1-972-410-7100.

    Distribution

    Nationwide and Canada.

    Quantity

    66 units.