Recall Z-2458-2019 ยท LCJ Tissue Expander And Accessories
Allergan PLC
McGhan Croissant-Shaped Tissue Expanders, Style 134 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.
| Date | Sep 11, 2019 (initiated Jul 24, 2019) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | UPDATE: On June 1, 2020, Allergan issued a press release outlining a dedicated multi-channel campaign to contact women who may not be aware of the Biocell recall and to improve tracking information for U. S. Breast Implant patients (link: https://news.abbvie.com/news/press-releases/allergan-aesthetics-launches-dedicated-multi-channel-campaign-to-contact-patients-who-may-not-be-aware-biocell-recall-and-to-improve-tracking-information-for-us-breast-implant-patients.htm) On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). R |
| Quantity | 4,026,287 Breast Implants and Tissue Expanders Combined in total |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER Mcghan Medical Corp., Jul 23, 1986 |