FDA Device recall Z-2464-2019
RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast…
- FDA Device
- Class I
- ongoing
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast… by Allergan, citing 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 lymph….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2464-2019 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2019-07-24 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Allergan |
| Distribution | US |
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.
Identifiers
| code_info | All Lots: Note:This product was not distributed within the US |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2464-2019%22
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