BEUDAMED
    FDA Recall Terminated

    TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor sternal bone quality.

    Recall: Z-1973-2010 · Initiated March 31, 2010

    Recall

    Recall Number
    Z-1973-2010
    Event Number
    55419
    Firm
    KARDIUM INC. 100
    FEI Number
    3007603855
    Product Code
    HXS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 31, 2010
    Posted
    July 9, 2010
    Terminated
    October 7, 2010
    Address
    12851 ROWAN PL., RICHMOND Canada British Columbia

    Description

    TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor sternal bone quality.

    Reason

    A component of the device is installed incorrectly which can result in the component falling out of the device and into the patient during use.

    Action

    The firm, Kardium, informed it's US distributor on March 30, 2010 by e-mail. The distributor was instructed to return all unused product to Kardium. The units remaining at hospitals will be returned to Kardium by the distributor sale reps. If you have any questions, please contact (604) 248-8891.

    Distribution

    Worldwide distribution: USA and Canada.

    Quantity

    420 units