{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189789", "product_res_number": "Z-0367-2022", "event_date_initiated": "2021-09-30", "event_date_created": "2021-12-10", "recall_status": "Open, Classified", "res_event_number": "88868", "product_code": "FWM", "pma_numbers": [ "P990075" ], "product_description": "MENTOR Saline-Filled Breast Implants are constructed from room temperature\nvulcanized 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_info": "Saline DV Breast Implant Codes with lots manufactured impacted by the Recall\nProduct Code/UDI GTIN Code:\n\n3501610/81317001171\nLot Numbers:\n9528016\n9558223\n\n3501620/81317001195\nLot Numbers:\n9576451\n9574053\n9574859\n\n3501625/81317001201\nLot Numbers:\n9539273\n9549488\n9567250\n9583791\n9585571\n9584309\n9587067\n\n3501630/81317001218\nLot Numbers:\n9534032\n9538574\n9546472\n9556176\n9570169\n9570471\n9572394\n9611046\n9611964\n9611603\n9622517\n\n3501635/81317001225\nLot Numbers:\n9529384\n9531109\n9540916\n9544819\n9535775\n9553669\n9552230\n9568916\n9566957\n9565272\n9575831\n9617819\n\n3501640/81317001232\nLot Numbers:\n9533837\n9537342\n9534030\n9534353\n9545543\n9553337\n9550675\n9555186\n9580874\n9583024\n9583793\n9590274\n9592612\n9614775\n9617814\n9614478\n\n3501645/81317001249\nLot Numbers:\n9530917\n9531112\n9535132\n9540919\n9546777\n9550164\n9550487\n9547976\n9549490\n9559882\n9578300\n9580414\n9582184\n9583026\n9582572\n9631722\n9629900\n\n3501650/81317001256\nLot Numbers:\n9529112\n9534355\n9527435\n9542799\n9550485\n9553671\n9553110\n9573299\n9576971\n9576298\n9574861\n9577403\n9576683\n9587327\n9590029\n9589074\n9611045\n9611601\n9629494\n\n3501655/81317001263\nLot Numbers:\n9535386\n9539275\n9547111\n9553108\n9555184\n9555923\n9569246\n9557445\n9597482\n9600888\n9603191\n9598143\n9605660\n9607486\n\n3501660/81317001270\nLot Numbers:\n9533291\n9528580\n9537339\n9553339\n9558222\n9559143\n9561193\n9582182\n9583025\n9591674\n9611963\n9614772\n9614480\n9614774\n9615516\n\n3501670/81317001287\nLot Numbers:\n9527187\n9528578\n9538081\n9542801\n9547114\n9561195\n9567890\n9559141\n9595692\n9597741\n9615898\n9619996\n\n3501680/81317001294\nLot Numbers:\n9530517\n9545545\n9562724\n9584036\n9585573\n9615518\n\n3501685/81317001300\nLot Numbers:\n9541786\n9546779\n9555187\n9574051\n9616933\n\n3501690/81317001317\nLot Numbers:\n9543357\n9547972\n9602499\n9602765\n\n3501695/81317001324\nLot Numbers:\n9544816\n9552232\n9563943\n\n3502200/81317001355\nLot Numbers:\n9532948\n9550672\n9607487\n9611604\n\n3502225/81317001362\nLot Numbers:\n9550484\n9553670\n9595693\n9596802\n9596397\n9598144\n\n3502250/81317001379\nLot Numbers:\n9535133\n9539276\n9551037\n9555185\n9547973\n9550165\n9584310\n9586121\n9604456\n9599498\n\n3502275/81317001386\nLot Numbers:\n9530516\n9533839\n9535387\n9541225\n9550674\n9547975\n9576452\n9576296\n9576970\n9578064\n9608063\n9608403\n9608792\n9612273\n\n3502300/81317001393\nLot Numbers:\n9530520\n9535778\n9536100\n9541463\n9546473\n9561861\n9563096\n9564279\n9565713\n9564913\n9569248\n9589073\n9589650\n9592613\n9592326\n9606471\n9614988\n9615519\n9629493\n\n3502325/81317001409\nLot Numbers:\n9526975\n9528017\n9528840\n9529386\n9530916\n9541788\n9557442\n9555926\n9569687\n9570166\n9571639\n9570470\n9573063\n9578066\n9576684\n9577401\n9596800\n9597739\n9615895\n\n3502350/81317001416\nLot Numbers:\n9530518\n9535773\n9533290\n9535131\n9536098\n9541227\n9546471\n9552229\n9553109\n9556177\n9555924\n9573300\n9570168\n9570472\n9571641\n9572393\n9587065\n9587328\n9589652\n9591673\n9594299\n9606470\n9614773\n9614987\n9610033\n9608402\n9614989\n\n3502375/81317001423\nLot Numbers:\n9544817\n9546175\n9546177\n9550163\n9556606\n9554350\n9555922\n9556604\n9553338\n9567249\n9568915\n9569689\n9584308\n9585572\n9598142\n9599496\n9600886\n9608064\n9625685\n9624985\n\n3502400/81317001430\nLot Numbers:\n9529875\n9538082\n9541466\n9541784\n9545544\n9549491\n9554347\n9563941\n9564916\n9562722\n9592611\n9615896\n9616495\n9617818\n\n3502425/81317001447\nLot Numbers:\n9530519\n9534033\n9538572\n9543627\n9551034\n9559144\n9559516\n9563098\n9567889\n9611044\n9611600\n9612274\n9614477\n9632676\n\n3502450/81317001454\nLot Numbers:\n9531110\n9543358\n9546178\n9553668\n9558850\n9568917\n9569245\n9571293\n9571640\n9570473\n9573298\n9602500\n9603190\n9606468\n9611602\n\n3502475/81317001461\nLot Numbers:\n9540917\n9537341\n9554349\n9567891\n9569247\n9602497\n9603192\n9608794\n\n3502500/81317001478\nLot Numbers:\n9538080\n9543990\n9547112\n9558851\n9558853\n9559518\n9589651\n9590028\n9594298\n9608795\n9610037\n9606469\n9626607\n\n3502550/81317001485\nLot Numbers:\n9532946\n9553111\n9556175\n9557444\n9594296\n9595426\n9596092\n9612272\n9616497\n\n3502600/81317001492\nLot Numbers:\n9535385\n9583792\n9586122\n9587326\n9612275\n9616499\n\n3502650/81317001508\nLot Numbers:\n9538083\n9551039\n9614479\n9615517\n\n3502700/81317001515\nLot Numbers:\n9567892\n9586783\n9588332\n9620460\n\n3502750/81317001522\nLot Numbers:\n9573064\n9576297\n9574860\n\n3502800/81317001539\nLot Numbers:\n9528841\n9525967\n9528839\n9527436\n9550486\n9561863\n9563939\n9565271\n9566958\n9565269\n9564915\n9571295\n9575830\n9630358\n9629166\n\n3503210/81317001584\nLot Numbers:\n9567251\n9595691\n\n3503230/81317001591\nLot Number:\n9574052\n\n3503250/81317001607\nLot Numbers:\n9545546\n9565270\n9591675\n9608404\n9610036\n9610034\n\n3503270/81317001614\nLot Numbers:\n9541783\n9558224\n9555925\n9611048\n9613076\n\n3503290/81317001621\nLot Numbers:\n9530727\n9541462\n9543989\n9563095\n9561862\n9565714\n9562723\n9559881\n\n3503310/81317001638\nLot Numbers:\n9527434\n9543628\n9538573\n9563942\n9529385\n9582571\n9584035\n9590027\n9602498\n9602766\n\n3503330/81317001645\nLot Numbers:\n9529113\n9529874\n9532947\n9528015\n9541228\n9536101\n9542800\n9552231\n9561194\n9558852\n9559517\n9559142\n9578299\n9580873\n9582861\n9580875\n9582183\n9584037\n9590273\n9588333\n9586784\n9587066\n9616932\n9617100\n\n3503380/81317001652\nLot Numbers:\n9533838\n9530728\n9534031\n9535776\n9540918\n9544818\n9546778\n9550673\n9556174\n9563097\n9557443\n9561864\n9568918\n9565712\n9563940\n9564914\n9569690\n9592325\n9594297\n9594634\n9597483\n9597738\n9599497\n9603193\n9617820\n\n3503420/81317001669\nLot Numbers:\n9529876\n9534354\n9531108\n9541226\n9540920\n9541785\n9551036\n9554348\n9556607\n9555927\n9559883\n9569688\n9571294\n9570167\n9595425\n9596396\n9596801\n9597740\n9602764\n9619316\n9619671\n9619995\n9622909\n9624982\n\n3503460/81317001676\nLot Numbers:\n9546176\n9541787\n9547113\n9549489\n9558225\n9592614\n9594633\n9594635\n9595427\n9596093\n9596091\n\n3503500/81317001683\nLot Numbers:\n9530918\n9536099\n9541465\n9539274\n9543991\n9553340\n9556605\n9579267\n9580876\n9592327\n9597481\n9600887\n9604455\n\n3503560/81317001690\nLot Numbers:\n9533292\n9538571\n9547974\n9578301\n9579266\n9580415\n9582573\n\n3503630/81317001706\nLot Numbers:\n9531111\n9533840\n9537340\n9543626\n9546780\n9575829\n9576454\n9578063\n9578065\n9608405\n\nSaline DV Breast Implant Codes without lots manufactured impacted by the Recall\nMENTOR Smooth Round Saline DV Implant\t350-1615/00081317001188\nMENTOR Smooth Round Saline DV Implant\t350-1697/00081317001331\nMENTOR Smooth Round Saline DV Implant\t350-2175/00081317001348\nMENTOR Smooth Round Saline DV Implant\t350-3170/00081317001560\nMENTOR Smooth Round Saline DV Implant\t350-3190/00081317001577", "firm_fei_number": "1000118360", "recalling_firm": "Mentor Texas, LP.", "address_1": "3041 Skyway Cir N 3041 Skyway Cir", "city": "Irving", "state": "TX", "postal_code": "75038-3524", "additional_info_contact": "Debra Smith\n972-252-6060", "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.", "root_cause_description": "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.\n\nCustomers are instructed to:\n1. Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s).\n2. 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.\n3. 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.\n4. 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.\n5. 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.\n6. 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.\n7. 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", "product_quantity": "28,348 implants", "distribution_pattern": "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.", "openfda": { "pma_number": [ "P990074", "P990075", "P120011" ], "registration_number": [ "1645337", "1649518", "3010531069", "2011068", "3011310987", "3022978896", "9617229", "3005423519" ], "fei_number": [ "1000118360", "3001236277", "3010531069", "2011068", "3006165545", "3006108784", "3011310987", "3022978896" ], "device_name": "Prosthesis, Breast, Inflatable, Internal, Saline", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3530", "device_class": "3" } } ] }