Recall Z-2464-2019— Allergan PLC

Name: FDA recall Z-2464-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-24

Class I · Ongoing

Class I FDA medical device recall by Allergan PLC, initiated 2019-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction. 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..

Recalling firm: Allergan PLC
Classification: Class I
Status: Ongoing
Initiated: 2019-07-24
Firm location: Irvine, CA, United States

Product description

RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.