FDAFDA · Food and drugs·Recall number Z-2451-2019
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800; Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690; Syle 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction
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 Product Style 163: 163-360/10888628000704;163-440/10888628000711;163-530/10888628000728;163-655/10888628000735;163-780/10888628000742 Product Style 168: 168-120/10888628000759;168-150/10888628000766;168-180/10888628000773;168-210/10888628000780;168-240/10888628000797;168-270/10888628000803;168-300/10888628000810;168-330/10888628000827;168-360/10888628000834;168-390/10888628000841;168-420/10888628000858;168-450/10888628000865;168-480/10888628000872;168-510/10888628000889;168-550/10888628000896;168-600/10888628000902;168-650/10888628000919;168-700/10888628000926;168-750/10888628000933;168-800/10888628000940 Style 363: 363LF-170/10888628000957;363LF-200/10888628000964;363LF-230/10888628000971;363LF-260/10888628000988;363LF-300/10888628000995;363LF-330/10888628001008;363LF-370/10888628001015;363LF-410/10888628001022;363LF-450/10888628001039;363LF-510/10888628001046; 363LF-560/10888628001053;363LF-620/10888628001060;363LF-690/10888628001077; Style 468: 468-195/10888628001084;468-230/10888628001091;468-270/10888628001107;468-300/10888628001114;468-350/10888628001121;468-380/10888628001138;468-450/10888628001145;468-495/10888628001152;468-560/10888628001169;468-620/10888628001176
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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