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Natrelle INSPIRA Breast Implants

Allergan, Inc. · Model TRL-230 · UDI-DI 10888628007697

FTR Prescription
0
510(k) clearances
231,867
Adverse events (138 deaths)
14
Recalls
8
Facilities

Description

NATRELLE INSPIRA Sty TRL-230 Low profile BIOCELL |textured|round|silicone

Recalls

DateFirmReason
2019-11-06Allergan PLCThe firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-l
2019-11-06Allergan PLCThe firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-l
2019-07-24Allergan PLCThe 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 lympho
2019-07-24Allergan PLCThe 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 lympho
2019-07-24Allergan PLCThe 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 lympho
2019-07-24Allergan PLCThe 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 lympho
2019-07-24Allergan PLCThe 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 lympho
2019-07-24Allergan PLCThe 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 lympho
2019-07-24Allergan PLCThe 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 lympho
2019-07-24Allergan PLCThe 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 lympho

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.