Recall Z-3065-2017 ยท N/A
Shippert Medical Technologies
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
| Date | Jun 1, 2017 |
| Status | Terminated |
| Reason | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. |
| Root cause | Packaging |
| 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. |
| Quantity | 5,188 units total |
| 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 Kuwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.