Recall record at a glance
| Official record | Z-2461-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Ongoing |
| Recalling firm | Allergan PLC |
| Report date | Sep 18, 2019 |
| Recall initiation date | Jul 24, 2019 |
| Quantity | 4,026,287 Breast Implants and Tissue Expanders Combined in total |
| Location | Irvine, CA, United States |
Official product description
Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Press Release.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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