BEUDAMED
    FDA Recall Terminated

    D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

    Recall: Z-0916-2013 · Initiated January 24, 2013

    Recall

    Recall Number
    Z-0916-2013
    Event Number
    64367
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    GEY
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 24, 2013
    Posted
    March 6, 2013
    Terminated
    July 5, 2013
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone

    Reason

    The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.

    Action

    Linvatec Corp sent an "URGENT: Medical Device Recall Notification" letter dated January 24, 2013 to its customers after initial phone notifications. The letter describes the affected product, problem and actions to be taken. Customers were instructed to immediate check facility's inventory for the affected product, use the enclosed FedEx air-bill when returning the product, and complete and return to the Recall Reply Form. For questions contact your Customer Service department at 800-535-8536 or fax at 727-319-5701 or email [email protected].

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore

    Quantity

    31 units