# FDA recall Z-0367-2022

> **Mentor Texas, LP.** · Class II · device recall initiated 2021-09-30.

## 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.

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0367-2022
- **Recalling firm:** Mentor Texas, LP.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-30
- **Report date:** 2021-12-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0367-2022

## Citation

> AI Analytics. FDA recall Z-0367-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0367-2022. Source: US FDA. Licensed CC0.

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