FDA-Device2021-12-22Class II
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.
Mentor Texas, LP.
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.
Sold states
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.
Affected count
28,348 implants
Manufactured in
3041 Skyway Cir N, Irving, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0367-2022Don't want to check this manually?
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