BEUDAMED
    FDA Enforcement Class II Terminated

    Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

    Recall: Z-1167-2014 · Reported March 19, 2014

    Enforcement

    Recall Number
    Z-1167-2014
    Event ID
    67183
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2014
    Initiation Date
    July 22, 2013
    Classification Date
    March 11, 2014
    Termination Date
    April 21, 2015
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

    Reason

    During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

    Code Info

    SGKIT (SGTRAY)

    Distribution

    Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.

    Quantity

    21