BEUDAMED
    FDA Recall Terminated

    ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    Recall: Z-2026-2010 · Initiated October 29, 2009

    Recall

    Recall Number
    Z-2026-2010
    Event Number
    54521
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    GEY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2009
    Posted
    July 17, 2010
    Terminated
    August 19, 2010
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    ADVANTAGE Turbo 2-Button Shaver. Rx Only, Made In USA, NON STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    Reason

    ConMed Linvatec is recalling Advantage, 2-Button Turbo Handpiece Catalog Number D9924. These products may self-activate due to moisture intrusion into the housing body. This issue has been isolated to products manufactured between June 7, 2004 and June 1, 2006.

    Action

    ConMed Linvatech notified affected customers by letter sent by FedEx next day delivery. Customers were asked to complete a response form and indicated if they have the product or have transferred the product. A Service Request number will be assigned for the returned product. Additional questions are directed to the firm's Customer Service department at 800-535-8536.

    Distribution

    Worldwide distribution. Products were distributed domestically throughout the U.S. Also United Arab Emirates, Argentina, Australia, Belgium, Switzerland, Chile, China, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, India, Italy, Japan, Lithuania, Morocco, Netherlands, New Zealand, Singapore, Turkey, South Africa.

    Quantity

    2,373