Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-4101
Check against the official notice below — it lists the full affected range.
Allergan PLC is recalling Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants with textured surfaces (Biocell) in multiple styles and sizes. The recall affects approximately 4 million implants distributed worldwide, including throughout all 50 U.S. states, U.S. territories, and international locations including Canada, Japan, Korea, and other countries. The recall was initiated following FDA notification of updated global safety information showing a higher incidence of anaplastic large cell lymphoma (BIA-ALCL), a type of cancer, in patients who have received textured breast implants.
The recall affects specific product code numbers and style designations (LL, LM, LF, LX, ML, MM, and MF) across all lots of the implant product. The source document does not specify a remedy for consumers who have received these implants.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide Distribution and US Nationwide All 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). OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam. Quantity: 4,026,287 Breast Implants and Tissue Expanders Combined in total Lot/code info: ALL LOTS Product Code/UDI Style LL: LL-410135/10888628003170,LL-410180/10888628003187,LL-410210/10888628003194,LL-410240/10888628003200,LL-410300/10888628003217; Style LM: LM-410140/10888628003224,LM-410190/10888628003231,LM-410220/10888628003248,LM-410250/10888628003255,LM-410320/10888628003262; Style LF: LF-410125/10888628003057,LF-410150/10888628003064,LF-410175/10888628003071,LF-410205/10888628003088,LF-410240/10888628003095,LF-410270/10888628003101,LF-410310/10888628003118,LF-410390/10888628003125,LF-410440/10888628003132,LF-410490/10888628003149,LF-410540/10888628003156,LF-410595/10888628003163; Style LX: LX-410145/10888628003279,LX-410175/10888628003286,LX-410195/10888628003293,LX-410225/10888628003309,LX-410255/10888628003316,LX-410290/10888628003323,LX-410330/10888628003330,LX-410365/10888628003347,LX-410405/10888628003354,LX-410455/10888628003361,LX-410515/10888628003378,LX-410570/10888628003385,LX-410625/10888628003392; Style ML: ML-410125/10888628003538,ML-410170/10888628003545,ML-410195/10888628003552,ML-410220/10888628003569,ML-410285/10888628003576; Style MM: MM-410160 10888628003583,MM-410185/10888628003590,MM-410215/10888628003606,MM-410245/10888628003613,MM-410280/10888628003620,MM-410320/10888628003637,MM-410360/10888628003644,MM-410400/10888628003651,MM-410450/10888628003668; Style MF:MF-410140/10888628003408,MF-410165/10888628003415,MF-410195/10888628003422,MF-410225/10888628003439,MF-410255/10888628003446,MF-410295/10888628003453,MF-410335/10888628003460
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.