Events

Recall of Device Recall TissueTrans Product Line

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Shippert Medical Technologies.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77518
  • Event Risk Class
    Class 2
  • Event Number
    Z-3063-2017
  • Event Initiated Date
    2017-06-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156208
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    unknown device name - Product Code N/A
  • 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.

Device

Device Recall TissueTrans Product Line
  • Model / Serial
    Lot Numbers 12047, 12077, 61235.
  • 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.
  • Product Description
    Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. || Product Usage: || Intended for fat transfer and liposuction.
  • Manufacturer
    Shippert Medical Technologies

Manufacturer

Shippert Medical Technologies
  • Manufacturer Address
    Shippert Medical Technologies, 6248 S Troy Cir Ste A, Centennial CO 80111-6485
  • Manufacturer Parent Company (2017)
    Shippert Medical Technologies Inc
  • Source
    USFDA