FDA Device recall Z-0367-2022
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane
- FDA Device
- Class II
- ongoing
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane by Mentor Texas, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0367-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-30 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mentor Texas |
| Distribution | US |
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
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.
Identifiers
| code_info | Saline DV Breast Implant Codes with lots manufactured impacted by the Recall Product Code/UDI GTIN Code: 3501610/81317…Saline DV Breast Implant Codes with lots manufactured impacted by the Recall Product Code/UDI GTIN Code: 3501610/81317001171 Lot Numbers: 9528016 9558223 3501620/81317001195 Lot Numbers: 9576451 9574053 9574859 3501625/81317001201 Lot Numbers: 9539273 9549488 9567250 9583791 9585571 9584309 9587067 3501630/81317001218 Lot Numbers: 9534032 9538574 9546472 9556176 9570169 9570471 9572394 9611046 9611964 9611603 9622517 3501635/81317001225 Lot Numbers: 9529384 9531109 9540916 9544819 9535775 9553669 9552230 9568916 9566957 9565272 9575831 9617819 3501640/81317001232 Lot Numbers: 9533837 9537342 9534030 9534353 9545543 9553337 9550675 9555186 9580874 9583024 9583793 9590274 9592612 9614775 9617814 9614478 3501645/81317001249 Lot Numbers: 9530917 9531112 9535132 9540919 9546777 9550164 9550487 9547976 9549490 9559882 9578300 9580414 9582184 9583026 9582572 9631722 9629900 3501650/81317001256 Lot Numbers: 9529112 9534355 9527435 9542799 9550485 9553671 9553110 9573299 9576971 9576298 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0367-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.