International safety notice
Alert 2770 (Technovigilance) - Allergan - Textured Breast Implants - Precautionary suspension of the import, sale and use of products, determined by Resolution-RE No. 3,340, of December 20, 2018.
Brazil / Anvisa · BRA · Jan 15, 2019
Key facts
| Title | Alert 2770 (Technovigilance) - Allergan - Textured Breast Implants - Precautionary suspension of the import, sale and use of products, determined by Resolution-RE No. 3,340, of December 20, 2018. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: CUI Allergan Textured Surface Breast Implant (registration no. 80143600099), Natrelle Allergan Textured Breast Implant (registration no. 80143600100), Natrelle Allergan Textured Double Lumen Breast Implant and Accessories (registration no. 80143600102) and BRST Aller Textured Breast Implant gan (registration no. 80143600107) Technical Name: Breast Prostheses ANVISA registration number: 80143600099; Risk Class: III Affected model: All units of products referring to registration numbers 80143600099, 80143600100, 80143600102 and 80143600107 Affected serial numbers: All product units referring to registration numbers 80143600099, 80143600100, 80143600102 and 80143600107 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ALLERGAN PRODUTOS FARMACÊUTICOS LTDA CNPJ 43426626000177 AVENIDA ENGENHEIRO LUÍS CARLOS BERRINI 105 18 ANDAR CONJ 181 E 182 TORRE 3 SETOR B COND THERA ONE CIDADE MONÇÕES SÃO PAULO SÃO PAULO TEL 11 30480516 EMAIL SIQUEIRALAISALLERGANCOM FABRICANTE DO PRODUTO ALLERGAN COSTA RICA SRL 900 PARKWAY LA AURORA HEREDIA COSTA RICA ALLERGAN REINO UNIDO |
| Models | 80143600100, 80143600102, 80143600099, 80143600107 |
| Date | Jan 15, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1