Reported Dec 22, 2021 · Ongoing
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of…
Mentor Texas, LP.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mentor Texas, LP. · 3041 Skyway Cir N · Irving, TX · 75038-3524
Is this the product you have?
- 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.
- Lot codes and dates
47 of 47 products
Products covered by this recall # Barcodes Product as published 1 Lot Numbers: 9528016 9558223 3501620/81317001195 2 Lot Numbers: 9576451 9574053 9574859 3501625/81317001201 3 Lot Numbers: 9539273 9549488 9567250 9583791 9585571 9584309 9587067 3501630/81317001218 4 Lot Numbers: 9534032 9538574 9546472 9556176 9570169 9570471 9572394 9611046 9611964 9611603 9622517 3501635/81317001225 5 Lot Numbers: 9529384 9531109 9540916 9544819 9535775 9553669 9552230 9568916 9566957 9565272 9575831 9617819 3501640/81317001232 6 Lot Numbers: 9533837 9537342 9534030 9534353 9545543 9553337 9550675 9555186 9580874 9583024 9583793 9590274 9592612 9614775 9617814 9614478 3501645/81317001249 7 Lot Numbers: 9530917 9531112 9535132 9540919 9546777 9550164 9550487 9547976 9549490 9559882 9578300 9580414 9582184 9583026 9582572 9631722 9629900 3501650/81317001256 8 Lot Numbers: 9529112 9534355 9527435 9542799 9550485 9553671 9553110 9573299 9576971 9576298 9574861 9577403 9576683 9587327 9590029 9589074 9611045 9611601 9629494 3501655/81317001263 9 Lot Numbers: 9535386 9539275 9547111 9553108 9555184 9555923 9569246 9557445 9597482 9600888 9603191 9598143 9605660 9607486 3501660/81317001270 10 Lot Numbers: 9533291 9528580 9537339 9553339 9558222 9559143 9561193 9582182 9583025 9591674 9611963 9614772 9614480 9614774 9615516 3501670/81317001287 11 Lot Numbers: 9527187 9528578 9538081 9542801 9547114 9561195 9567890 9559141 9595692 9597741 9615898 9619996 3501680/81317001294 12 Lot Numbers: 9530517 9545545 9562724 9584036 9585573 9615518 3501685/81317001300 13 Lot Numbers: 9541786 9546779 9555187 9574051 9616933 3501690/81317001317 14 Lot Numbers: 9543357 9547972 9602499 9602765 3501695/81317001324 15 Lot Numbers: 9544816 9552232 9563943 3502200/81317001355 16 Lot Numbers: 9532948 9550672 9607487 9611604 3502225/81317001362 17 Lot Numbers: 9550484 9553670 9595693 9596802 9596397 9598144 3502250/81317001379 18 Lot Numbers: 9535133 9539276 9551037 9555185 9547973 9550165 9584310 9586121 9604456 9599498 3502275/81317001386 19 Lot Numbers: 9530516 9533839 9535387 9541225 9550674 9547975 9576452 9576296 9576970 9578064 9608063 9608403 9608792 9612273 3502300/81317001393 20 Lot Numbers: 9530520 9535778 9536100 9541463 9546473 9561861 9563096 9564279 9565713 9564913 9569248 9589073 9589650 9592613 9592326 9606471 9614988 9615519 9629493 3502325/81317001409 - Amount recalled
- 28,348 implants
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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