BEUDAMED
    FDA Recall Terminated

    Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.

    Recall: Z-3064-2017 · Initiated June 1, 2017

    Recall

    Recall Number
    Z-3064-2017
    Event Number
    77518
    Firm
    Shippert Medical Technologies
    FEI Number
    3008719017
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 1, 2017
    Terminated
    January 30, 2024
    Address
    6248 S Troy Cir, Ste A, Centennial, CO, 80111-6485

    Description

    Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.

    Reason

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

    Action

    Customers were notified of the recall between 06/01/2017 and 06/14/2017 via FedEx letter. Instructions included remove and quarantine all affected devices, complete and return the response form, arrange for the return of affected devices, and notify any customers if further distributed.

    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