BEUDAMED
    FDA Recall Terminated

    ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source

    Recall: Z-2456-2012 · Initiated May 20, 2011

    Recall

    Recall Number
    Z-2456-2012
    Event Number
    63009
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    GCT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 20, 2011
    Posted
    September 25, 2012
    Terminated
    September 26, 2012
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source

    Reason

    Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.

    Action

    Linvatec Corporation sent an "URGENT Medical Device Recall Notification letter dated May 20, 2011 to its customers via FedEx service. Firm advised their suppliers of the Light Sources potentially has unapproved components and does not meet the finished product requirement. The distributors and end user level are advised if any affected product is in their possession can be used until returned for advance exchange. The customers were instructed to: 1) locate the identified product by serial number at your facility and complete the Reply Form attached; 2) Contact ConMed Linvatec Customer Service (800-237-0169) to receive SR Number Advance Exchange affected product only. Once Customer Service authorizes the SR Number your Advance Exchange Light Source will be shipped to your facility; 3) Once replacement unit is received, utilize the packaging material to return the recalled Light Source to ConMed Linvatec using the enclosed FedEx Airway Bill. Mail or FAX copy of Reply Form to ConMed Linvatec; 4) Complete and return a copy of the Reply Form. For questions contact your local ConMed Linvatec office or email [email protected], Customer Service at 800-237-0169 or fax to 727-319-5701.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.

    Quantity

    57