BEUDAMED
    FDA Enforcement Class II Terminated

    Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.

    Recall: Z-1934-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1934-2013
    Event ID
    65837
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Xomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    July 9, 2013
    Classification Date
    August 9, 2013
    Termination Date
    September 25, 2014
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218, United States

    Description

    Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.

    Reason

    The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"

    Code Info

    ALL Lots of the following models: Model 3717000 = 2 Level Instrument tray Model 3717001 = 3 Level tray (metal & radel) Model 3717006 = 2 Level Instruument tray with mat Model 3717026 = House Otology Set tray Model 3722301 = Wiet Chronic Ear Set tray Model 3747108 = Skykes Endobrow Lift tray Model 960374 = framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 Model 960-619 = LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) Model MCOH0SC = Otology Plastic instrument tray Model MCO649SC = Middle Ear Instrument tray Model MCOS10SC = Instrument tray 2 level Model MCLS28 = MF Sataloff Complete Instrument tray Model MCLS37 = Sataloff Picks/Handles/Neddles Instrument tray Model 3319005 = Powerforma Bur Rack tray * instrument set that includes the identified tray

    Distribution

    Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Australia, New Zealand, Singapore, Thailand, Vietnam, China, Hong Kong,Taiwan, Korea, Japan, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, and Venezuela.

    Quantity

    3,562 trays