{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 15 } }, "results": [ { "cfres_id": "175500", "product_res_number": "Z-2451-2019", "event_date_initiated": "2019-07-24", "event_date_posted": "2019-09-11", "recall_status": "Open, Classified", "res_event_number": "83500", "product_code": "FWM", "pma_numbers": [ "P990074" ], "product_description": "Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers:\n\nStyle 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC;\n\nStyle 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800;\n\nStyle 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690;\n\nSyle 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620\n\nThese products may have been sold under the McGhan, Inamed or NATRELLE brands. \n\nProduct Usage: Breast augmentation and Breast reconstruction", "code_info": "ALL LOTS   Product Code/UDI  Product Style 163: 163-360/10888628000704;163-440/10888628000711;163-530/10888628000728;163-655/10888628000735;163-780/10888628000742   Product Style 168: 168-120/10888628000759;168-150/10888628000766;168-180/10888628000773;168-210/10888628000780;168-240/10888628000797;168-270/10888628000803;168-300/10888628000810;168-330/10888628000827;168-360/10888628000834;168-390/10888628000841;168-420/10888628000858;168-450/10888628000865;168-480/10888628000872;168-510/10888628000889;168-550/10888628000896;168-600/10888628000902;168-650/10888628000919;168-700/10888628000926;168-750/10888628000933;168-800/10888628000940  Style 363: 363LF-170/10888628000957;363LF-200/10888628000964;363LF-230/10888628000971;363LF-260/10888628000988;363LF-300/10888628000995;363LF-330/10888628001008;363LF-370/10888628001015;363LF-410/10888628001022;363LF-450/10888628001039;363LF-510/10888628001046; 363LF-560/10888628001053;363LF-620/10888628001060;363LF-690/10888628001077;  Style 468: 468-195/10888628001084;468-230/10888628001091;468-270/10888628001107;468-300/10888628001114;468-350/10888628001121;468-380/10888628001138;468-450/10888628001145;468-495/10888628001152;468-560/10888628001169;468-620/10888628001176", "firm_fei_number": "2011068", "recalling_firm": "Allergan PLC", "address_1": "2525 Dupont Dr", "city": "Irvine", "state": "CA", "postal_code": "92612-1531", "additional_info_contact": "Nicole Katz\n714-246-4500", "reason_for_recall": "The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.", "root_cause_description": "Unknown/Undetermined by firm", "action": "UPDATE: On June 1, 2020, Allergan issued a press release outlining a dedicated multi-channel campaign to contact women who may not be aware of the Biocell recall and to improve tracking information for U. S. Breast Implant patients (link: https://news.abbvie.com/news/press-releases/allergan-aesthetics-launches-dedicated-multi-channel-campaign-to-contact-patients-who-may-not-be-aware-biocell-recall-and-to-improve-tracking-information-for-us-breast-implant-patients.htm) \n\nOn July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry. \n\nThe recall letter will inform customers to do the following:\n1.\tIf you have inventory of the recalled products, Quarantine product to prevent its use. \n2.\tConduct a physical count of the affected products in your possession and record the count on the enclosed Recall Stock Response Form.\n3.\tSend the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form.\n4.\tUpon receipt of the Response Form, Inmar will issue Return Authorization label(s).\n5.\tWhen returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to:\nInmar Rx Solutions, Inc.\n4332 Empire Rd. Fort Worth, TX 76155\n6.\tPlease Do Not return any products that are not the subject of this recall. \nPlease contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions. \n\nPatient letters were mailed on August 14, 19 and 26, 2019 to all impacted patients to which Allergan had complete names and addresses in their device tracking database. The patient letters informed customers of the following:\n\n1. How", "product_quantity": "4,026,287 Breast Implants and Tissue Expanders Combined in total", "distribution_pattern": "Worldwide Distribution and US Nationwide \n\nAll fifty (50) US States, the US Virgin Islands and Puerto Rico. (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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY).\n\nOUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam.", "openfda": { "pma_number": [ "P990074", "P990075", "P120011" ], "registration_number": [ "3010531069", "1645337", "2011068", "9617229", "1649518", "3022978896", "3005423519", "3011310987" ], "fei_number": [ "3010531069", "3001236277", "2011068", "3022978896", "3006165545", "1000118360", "3011310987", "3006108784" ], "device_name": "Prosthesis, Breast, Inflatable, Internal, Saline", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3530", "device_class": "3" } } ] }