Device product
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
Z-3065-2017
Product summary
- Event
- Event 77518
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,188 units total
- Official record key
device-enforcement:Z-3065-2017
Official wording
Reason: Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Code information: Lot Numbers 12082, 12111, 61116, 61236, 61288, 61364, 61464.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.