MENTOR Saline-Filled Breast Implants are constructed from room… — Class II medical device recall Z-0367-2022
Ongoing recall by Mentor Texas, LP., reported 2021-12-22, distributed nationwide. Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the im
| Recall number | Z-0367-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mentor Texas, LP., Irving, TX, United States |
| Recall initiated | 2021-09-30 |
| Classified | 2021-12-10 |
| Reported by FDA | 2021-12-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, DE, ES, FR, GB, IE, KR, SG, TR, TW |
| Quantity | 28,348 implants |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00081317001188, 00081317001331, 00081317001348, 00081317001560, 00081317001577 |
| Lot numbers | 3501620/81317001195, 3501625/81317001201, 3501630/81317001218, 3501635/81317001225, 3501640/81317001232, 3501645/81317001249, 3501650/81317001256, 3501655/81317001263, 3501660/81317001270, 3501670/81317001287, 3501680/81317001294, 3501685/81317001300, 3501690/81317001317, 3501695/81317001324, 3502200/81317001355, 3502225/81317001362, 3502250/81317001379, 3502275/81317001386, 3502300/81317001393, 3502325/81317001409, 3502350/81317001416, 3502375/81317001423, 3502400/81317001430, 3502425/81317001447, 3502450/81317001454, 3502475/81317001461, 3502500/81317001478, 3502550/81317001485, 3502600/81317001492, 3502650/81317001508, 3502700/81317001515, 3502750/81317001522, 3502800/81317001539, 3503210/81317001584, 3503230/81317001591, 3503250/81317001607, 3503270/81317001614, 3503290/81317001621, 3503310/81317001638, 3503330/81317001645 and 460 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0367-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.