BEUDAMED
    FDA Enforcement Class II Terminated

    Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.

    Recall: Z-3065-2017 · Reported August 30, 2017

    Enforcement

    Recall Number
    Z-3065-2017
    Event ID
    77518
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shippert Medical Technologies
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 30, 2017
    Initiation Date
    June 1, 2017
    Classification Date
    August 22, 2017
    Termination Date
    January 30, 2024
    Address
    6248 S Troy Cir Ste A, Centennial, CO, 80111-6485, United States

    Description

    Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.

    Reason

    Seal integrity of the Tissu-Trans product sterile packages cannot be assured.

    Code Info

    Lot Numbers 12082, 12111, 61116, 61236, 61288, 61364, 61464.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV. and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea.

    Quantity

    5,188 units total