FDAFDA · Food and drugs·Recall number Z-2456-2019
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
Published September 18, 2019 · Recall initiated: July 24, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Allergan PLC
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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