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U.S. Department of Health and Human Services

Class 2 Device Recall Smooth Round Saline Diaphragm Valve (DV) Breast Implants

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  Class 2 Device Recall Smooth Round Saline Diaphragm Valve (DV) Breast Implants see related information
Date Initiated by Firm September 30, 2021
Create Date December 10, 2021
Recall Status1 Open3, Classified
Recall Number Z-0367-2022
Recall Event ID 88868
PMA Number P990075 
Product Classification Prosthesis, breast, inflatable, internal, saline - Product Code FWM
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.
Code Information 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 9574861 9577403 9576683 9587327 9590029 9589074 9611045 9611601 9629494 3501655/81317001263 Lot Numbers: 9535386 9539275 9547111 9553108 9555184 9555923 9569246 9557445 9597482 9600888 9603191 9598143 9605660 9607486 3501660/81317001270 Lot Numbers: 9533291 9528580 9537339 9553339 9558222 9559143 9561193 9582182 9583025 9591674 9611963 9614772 9614480 9614774 9615516 3501670/81317001287 Lot Numbers: 9527187 9528578 9538081 9542801 9547114 9561195 9567890 9559141 9595692 9597741 9615898 9619996 3501680/81317001294 Lot Numbers: 9530517 9545545 9562724 9584036 9585573 9615518 3501685/81317001300 Lot Numbers: 9541786 9546779 9555187 9574051 9616933 3501690/81317001317 Lot Numbers: 9543357 9547972 9602499 9602765 3501695/81317001324 Lot Numbers: 9544816 9552232 9563943 3502200/81317001355 Lot Numbers: 9532948 9550672 9607487 9611604 3502225/81317001362 Lot Numbers: 9550484 9553670 9595693 9596802 9596397 9598144 3502250/81317001379 Lot Numbers: 9535133 9539276 9551037 9555185 9547973 9550165 9584310 9586121 9604456 9599498 3502275/81317001386 Lot Numbers: 9530516 9533839 9535387 9541225 9550674 9547975 9576452 9576296 9576970 9578064 9608063 9608403 9608792 9612273 3502300/81317001393 Lot Numbers: 9530520 9535778 9536100 9541463 9546473 9561861 9563096 9564279 9565713 9564913 9569248 9589073 9589650 9592613 9592326 9606471 9614988 9615519 9629493 3502325/81317001409 Lot Numbers: 9526975 9528017 9528840 9529386 9530916 9541788 9557442 9555926 9569687 9570166 9571639 9570470 9573063 9578066 9576684 9577401 9596800 9597739 9615895 3502350/81317001416 Lot Numbers: 9530518 9535773 9533290 9535131 9536098 9541227 9546471 9552229 9553109 9556177 9555924 9573300 9570168 9570472 9571641 9572393 9587065 9587328 9589652 9591673 9594299 9606470 9614773 9614987 9610033 9608402 9614989 3502375/81317001423 Lot Numbers: 9544817 9546175 9546177 9550163 9556606 9554350 9555922 9556604 9553338 9567249 9568915 9569689 9584308 9585572 9598142 9599496 9600886 9608064 9625685 9624985 3502400/81317001430 Lot Numbers: 9529875 9538082 9541466 9541784 9545544 9549491 9554347 9563941 9564916 9562722 9592611 9615896 9616495 9617818 3502425/81317001447 Lot Numbers: 9530519 9534033 9538572 9543627 9551034 9559144 9559516 9563098 9567889 9611044 9611600 9612274 9614477 9632676 3502450/81317001454 Lot Numbers: 9531110 9543358 9546178 9553668 9558850 9568917 9569245 9571293 9571640 9570473 9573298 9602500 9603190 9606468 9611602 3502475/81317001461 Lot Numbers: 9540917 9537341 9554349 9567891 9569247 9602497 9603192 9608794 3502500/81317001478 Lot Numbers: 9538080 9543990 9547112 9558851 9558853 9559518 9589651 9590028 9594298 9608795 9610037 9606469 9626607 3502550/81317001485 Lot Numbers: 9532946 9553111 9556175 9557444 9594296 9595426 9596092 9612272 9616497 3502600/81317001492 Lot Numbers: 9535385 9583792 9586122 9587326 9612275 9616499 3502650/81317001508 Lot Numbers: 9538083 9551039 9614479 9615517 3502700/81317001515 Lot Numbers: 9567892 9586783 9588332 9620460 3502750/81317001522 Lot Numbers: 9573064 9576297 9574860 3502800/81317001539 Lot Numbers: 9528841 9525967 9528839 9527436 9550486 9561863 9563939 9565271 9566958 9565269 9564915 9571295 9575830 9630358 9629166 3503210/81317001584 Lot Numbers: 9567251 9595691 3503230/81317001591 Lot Number: 9574052 3503250/81317001607 Lot Numbers: 9545546 9565270 9591675 9608404 9610036 9610034 3503270/81317001614 Lot Numbers: 9541783 9558224 9555925 9611048 9613076 3503290/81317001621 Lot Numbers: 9530727 9541462 9543989 9563095 9561862 9565714 9562723 9559881 3503310/81317001638 Lot Numbers: 9527434 9543628 9538573 9563942 9529385 9582571 9584035 9590027 9602498 9602766 3503330/81317001645 Lot Numbers: 9529113 9529874 9532947 9528015 9541228 9536101 9542800 9552231 9561194 9558852 9559517 9559142 9578299 9580873 9582861 9580875 9582183 9584037 9590273 9588333 9586784 9587066 9616932 9617100 3503380/81317001652 Lot Numbers: 9533838 9530728 9534031 9535776 9540918 9544818 9546778 9550673 9556174 9563097 9557443 9561864 9568918 9565712 9563940 9564914 9569690 9592325 9594297 9594634 9597483 9597738 9599497 9603193 9617820 3503420/81317001669 Lot Numbers: 9529876 9534354 9531108 9541226 9540920 9541785 9551036 9554348 9556607 9555927 9559883 9569688 9571294 9570167 9595425 9596396 9596801 9597740 9602764 9619316 9619671 9619995 9622909 9624982 3503460/81317001676 Lot Numbers: 9546176 9541787 9547113 9549489 9558225 9592614 9594633 9594635 9595427 9596093 9596091 3503500/81317001683 Lot Numbers: 9530918 9536099 9541465 9539274 9543991 9553340 9556605 9579267 9580876 9592327 9597481 9600887 9604455 3503560/81317001690 Lot Numbers: 9533292 9538571 9547974 9578301 9579266 9580415 9582573 3503630/81317001706 Lot Numbers: 9531111 9533840 9537340 9543626 9546780 9575829 9576454 9578063 9578065 9608405 Saline DV Breast Implant Codes without lots manufactured impacted by the Recall MENTOR Smooth Round Saline DV Implant 350-1615/00081317001188 MENTOR Smooth Round Saline DV Implant 350-1697/00081317001331 MENTOR Smooth Round Saline DV Implant 350-2175/00081317001348 MENTOR Smooth Round Saline DV Implant 350-3170/00081317001560 MENTOR Smooth Round Saline DV Implant 350-3190/00081317001577
Recalling Firm/
Manufacturer		 Mentor Texas, LP.
3041 Skyway Cir N
Irving TX 75038-3524
For Additional Information Contact Debra Smith
972-252-6060
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On 10/11/2021, the Firm sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" Notfication via UPS informing customers that breast implants which have expiration dates from 01/01/2025 to 09/30/2021, due to a manufacturing issue may have a potentially weakened area on the base patch portion of the shell. As a result of this issue, these implants may prematurely deflate for which replacement surgery may be needed. Customers are instructed to: 1. Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax/email to Sedgwick at 888-912-7086 or mentor7209@sedgwick.com within 3 business days. Return the BRF even if they do not have product subject to this recall. 5. Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. While processing the returns, maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 7. Return unused impacted Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall that are in their inventory immediately. To receive credit reimbursement, customers must return product subject to this recall. Any non-affected product and any product returned after the dat
Quantity in Commerce 28,348 implants
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = FWM and Original Applicant = MENTOR WORLDWIDE LLC
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