FDAFDA · Food and drugs·Recall number Z-2463-2019
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM 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: Note:This product was not distributed within the US
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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