BEUDAMED
    FDA Recall Terminated

    Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.

    Recall: Z-0273-2009 · Initiated October 1, 2008

    Recall

    Recall Number
    Z-0273-2009
    Event Number
    49554
    Firm
    Gyrus ACMI Corporation
    FEI Number
    3003790304
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 1, 2008
    Posted
    November 5, 2008
    Terminated
    May 7, 2012
    Address
    136 Turnpike Road, Southborough, MA, 01772

    Description

    Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.

    Reason

    Sterility may be compromised

    Action

    Gyrus ACMI initiated a voluntary recall by an Urgent: Medical Device Recall letter on 10/01/08 informing accounts of the problem, cease any further use of the affected product, remove any of the affected product service representative to obtain a Return Goods Authorization, return the product, and complete the reply form and fax it to the Regulatory Affairs Dept. so that the response can be tracked.

    Distribution

    Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.

    Quantity

    1340 units