Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11, 133FV-12, 133FV-13, 133FV-14, 1
Check against the official notice below — it lists the full affected range.
Allergan PLC is recalling Natrelle 133 Tissue Expanders and related textured breast implants worldwide, including distribution across all 50 U.S. states, U.S. territories, and eight countries overseas. The recall affects approximately 4 million breast implants and tissue expanders combined and was initiated following FDA notification of updated global safety information showing a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients with textured breast implants.
The recalled products include multiple styles (133FV, 133MV, 133LV, 133FX, 133MX, 133SX, and 133SV) with specific lot numbers and product codes listed in the recall notice. The source 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 133FV: 133FV-11 10888628003927, 133FV-12 10888628003934, 133FV-13 10888628003941, 133FV-14 10888628003958, 133FV-15 10888628003965, 133FV-16 10888628003972; STYLE 133MV: 133MV-11 10888628004108, 133MV-12 10888628004115, 133MV-13 10888628004122, 133MV-14 10888628004139, 133MV-15 10888628004146, 133MV-16 10888628004153; STYLE 133LV: 133LV-11 10888628004047, 133LV-12 10888628004054, 133LV-13 10888628004061, 133LV-14 10888628004078, 133LV-15 10888628004085, 133LV-16 10888628004092; STYLE 133FX: 133FX-11 10888628003989, 133FX-12 10888628003996, 133FX-13 10888628004009, 133FX-14 10888628004016, 133FX-15 10888628004023, 133FX-16 10888628004030; STYLE 133MX: 133MX-11 10888628004160, 133MX-12 10888628004177, 133MX-13 10888628004184, 133MX-14 10888628004191, 133MX-15 10888628004207, 133MX-16 10888628004214; STYLE 133SX: 133SX-11 10888628003804, 133SX-12 10888628003811, 133SX-13 10888628003828, 133SX-14 10888628003835, 133SX-15 10888628003842, 133SX-16 10888628003859; STYLE 133SV: 133SV-11 10888628003866, 133SV-12 10888628003873, 133SV-13 10888628003880, 133SV-14 10888628003897, 133SV-15 10888628003903, 133SV-16 10888628003910;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.