Mentor Texas, LP. recalls MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polyd

Recalled December 22, 2021 · FDA recall Z-0367-2022 · Mentor Texas

Hazard

Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. · FDA Class II

Units

28,348 implants

Sold at

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Spain, UK, Germany, France, Korea, Australia, Taiwan, Belgium, Ireland, Turkey, and Singapore.

Description

Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

Product

MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.

Manufacturer(s)

Mentor Texas, LP.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →