FDA recall Z-3066-2017

Product

Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.

Reason for recall

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

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.

Key facts

Status

Terminated

Initiation date

2017-06-01

Report date

2017-08-30

Termination date

2024-01-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Centennial, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3066-2017