medical Class I Updated 2019-09-18

Allergan PLC recalls RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Im

Recalled Product

RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots: Note:This product was not distributed within the US
View official government recall

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