BEUDAMED
    FDA Enforcement Class III 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 · Reported March 13, 2013

    Enforcement

    Recall Number
    Z-0916-2013
    Event ID
    64367
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Linvatec Corp. dba ConMed Linvatec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 13, 2013
    Initiation Date
    January 24, 2013
    Classification Date
    March 6, 2013
    Termination Date
    July 5, 2013
    Address
    11311 Concept Blvd, N/A, Largo, FL, 33773-4908, United States

    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.

    Code Info

    Model #D3000

    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