Allergan PLC Recall: Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implan
Allergan PLC Recall: Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implan is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Allergan PLC; Product: Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast aug
| Recalling firm | Allergan PLC |
|---|---|
| Product | Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction |
| 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| 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, W |
| Recall initiated | 20190724 |
| Recall number | Z-2463-2019 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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