Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-FV-16; STYLE 133P-MV: 133P-MV-
Check against the official notice below — it lists the full affected range.
Allergan PLC is recalling approximately 4 million Natrelle 133 Plus textured breast implants and tissue expanders worldwide following FDA notification of updated safety information. The recall was initiated due to a higher incidence of anaplastic large cell lymphoma (BIA-ALCL), a type of cancer, found in patients with textured breast implants. The recalled products were distributed across all 50 U.S. states, U.S. territories, and several international countries including Canada, Japan, Korea, and others. Multiple product styles and lot numbers are included in this recall.
The source document does not specify what action affected consumers should take in response to this recall.
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 133P-FV:133P-FV-11 10888628009646, 133P-FV-11-T 10888628009653, 133P-FV-12 10888628009660, 133P-FV-12-T 10888628009677, 133P-FV-13 10888628009684, 133P-FV-13-T 10888628009691, 133P-FV-14 10888628009707, 133P-FV-14-T 10888628009714, 133P-FV-15 10888628009721, 133P-FV-15-T 10888628009738, 133P-FV-16 10888628009745; STYLE 133P-MV: 133P-MV-11 10888628010000, 133P-MV-12 10888628010024, 133P-MV-13 10888628010048, 133P-MV-14 10888628010062, 133P-MV-15 10888628010086, 133P-MV-16 10888628010109; STYLE 133P-LV: 133P-LV-11 10888628009882, 133P-LV-12 10888628009905, 133P-LV-13 10888628009929, 133P-LV-14 10888628009943, 133P-LV-15 10888628009967, 133P-LV-16 10888628009981; STYLE 133P-FX: 133P-FX-11 10888628009769, 133P-FX-12 10888628009783, 133P-FX-13 10888628009806, 133P-FX-14 10888628009820, 133P-FX-15 10888628009844, 133P-FX-16 10888628009868; STYLE 133P-MX: 133P-MX-11 10888628010123, 133P-MX-12 10888628010147, 133P-MX-13 10888628010161, 133P-MX-14 10888628010185, 133P-MX-15 10888628010208, 133P-MX-16 10888628010222; STYLE 133P-SX: 133P-SX-11 10888628010369, 133P-SX-12 10888628010383, 133P-SX-13 10888628010406, 133P-SX-14 10888628010420, 133P-SX-15 10888628010444, 133P-SX-16 10888628010468; STYLE 133P-SV: 133P-SV-11 10888628010246, 133P-SV-12 10888628010260, 133P-SV-13 10888628010284, 133P-SV-14 10888628010307, 133P-SV-15 10888628010321, 133P-SV-16 10888628010345; STYLE 133P-FV-T: 133P-FV-11-T 10888628009653, 133P-FV-12-T 10888628009677, 133P-FV-13-T 10
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.