BEUDAMED
    FDA Recall Terminated

    REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908. ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting and coagulation device and accessories, intended to remove tissue and control bleeding by use of high-frequency electrical current.

    Recall: Z-2051-2009 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-2051-2009
    Event Number
    52811
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 31, 2009
    Posted
    September 9, 2009
    Terminated
    February 25, 2011
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908. ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting and coagulation device and accessories, intended to remove tissue and control bleeding by use of high-frequency electrical current.

    Reason

    ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.

    Action

    ConMed Linvatec is notifying their direct consignees by an Urgent Medical Device Recall letter, requesting that customers check their inventory for the affected products; complete, sign, and return the Reply Form; and return of any affected lot numbers of the product. The product is to be returned to ConMed Linvatec. Questions should be directed to Customer Service at 1-800-237-0169.

    Distribution

    Worldwide Distribution

    Quantity

    28,074 units