FDA Device Recall Z-2456-2019

Allergan PLC · Irvine, CA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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-11, 133P-MV-12, 133P-MV-13, 133P-MV-14, 133P-MV-15, 133P-MV-16; STYLE 133P-LV: 133P-LV-11, 133P-LV-12, 133P-LV-13, 133P-LV-14, 133P-LV-15, 133P-LV-16; STYLE 133P-FX: 133P-FX-11, 133P-FX-12, 133P-FX-13, 133P-FX-14, 133P-FX-15, 133P-FX-16; STYLE 133P-MX:133P-MX-11,133P-MX-12, 133P-MX-13, 133P-MX-14, 133P-MX-15, 133P-MX-16; STYLE 133P-SX: 133P-SX-11, 133P-SX-12, 133P-SX-13, 133P-SX-14, 133P-SX-15, 133P-SX-16; STYLE 133P-SV: 133P-SV-11,133P-SV-12, 133P-SV-13, 133P-SV-14, 133P-SV-15, 133P-SV-16; STYLE 133P-FV-T:133P-FV-11-T, 133P-FV-12-T, 133P-FV-13-T, 133P-FV-14-T, 133P-FV-15-T, 133P-FV-16-T; STYLE 133P-MV-T: 133P-MV-11-T, 133P-MV-12-T, 133P-MV-13-T, 133P-MV-14-T, 133P-MV-15-T, 133P-MV-16-T; STYLE 133P-LV-T: 133P-LV-11-T, 133P-LV-12-T, 133P-LV-13-T, 133P-LV-14-T, 133P-LV-15-T, 133P-LV-16-T; STYLE 133P-FX-T: 133P-FX-11-T, 133P-FX-12-T, 133P-FX-13-T, 133P-FX-14-T, 133P-FX-15-T, 133P-FX-16-T; STYLE 133P-MX-T: 133P-MX-11-T, 133P-MX-12-T, 133P-MX-13-T, 133P-MX-14-T, 133P-MX-15-T, 133P-MX-16-T; STYLE 133P-SX-T: 133P-SX-11-T, 133P-SX-12-T, 133P-SX-13-T, 133P-SX-14-T, 133P-SX-15-T, 133P-SX-16-T; STYLE 133P-SV-T: 133P-SV-11-T, 133P-SV-12-T, 133P-SV-13-T, 133P-SV-14-T, 133P-SV-15-T, 133P-SV-16-T These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed

Lot / serial / GTIN: 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 10888628009691, 133P-FV-14-T 10888628009714, 133P-FV-15-T 10888628009738, 133P-FV-16-T 10888628009752; STYLE 133P-MV-T: 133P-MV-11-T 10888628010017, 133P-MV-12-T 10888628010031, 133P-MV-13-T 10888628010055, 133P-MV-14-T 10888628010079, 133P-MV-15-T 10888628010093, 133P-MV-16-T 10888628010116; STYLE 133P-LV-T: 133P-LV-11-T 10888628009899, 133P-LV-12-T 10888628009912, 133P-LV-13-T 10888628009936, 133P-LV-14-T 10888628009950, 133P-LV-15-T 10888628009974, 133P-LV-16-T 10888628009998; STYLE 133P-FX-T: 133P-FX-11-T 10888628009776, 133P-FX-12-T 10888628009790, 133P-FX-13-T 10888628009813, 133P-FX-14-T 10888628009837, 133P-FX-15-T 10888628009851, 133P-FX-16-T 10888628009875; STYLE 133P-MX-T: 133P-MX-11-T 10888628010130, 133P-MX-12-T 10888628010154, 133P-MX-13-T 10888628010178, 133P-MX-14-T 10888628010192, 133P-MX-15-T 10888628010215, 133P-MX-16-T 10888628010239; STYLE 133P-SX-T: 133P-SX-11-T 10888628010376, 133P-SX-12-T 10888628010390, 133P-SX-13-T 10888628010413, 133P-SX-14-T 10888628010437, 133P-SX-15-T 10888628010451, 133P-SX-16-T 10888628010475; STYLE 133P-SV-T: 133P-SV-11-T 10888628010253, 133P-SV-12-T 10888628010277, 133P-SV-13-T 10888628010291, 133P-SV-14-T 10888628010314, 133P-SV-15-T 10888628010338, 133P-SV-16-T 10888628010352

Quantity: 4,026,287 Breast Implants and Tissue Expanders Combined in total

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.

Recall record

Recall number: Z-2456-2019
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
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.
Recall initiated: 2019-07-24
Classified by FDA Center: 2019-09-11
FDA published: 2019-09-18
Recalling firm: Allergan PLC
Firm location: Irvine, CA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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