International safety notice
Alert 2927 (Technosurveillance) - Allergan - Textured Breast Implants Recall of BIOCELL textured breast implants and tissue expanders.
Brazil / Anvisa · BRA · Jul 25, 2019
Key facts
| Title | Alert 2927 (Technosurveillance) - Allergan - Textured Breast Implants Recall of BIOCELL textured breast implants and tissue expanders. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Natrelle Textured Tissue Expander and Allergan Accessories (registration 80143600096), Natrelle Allergan Textured Breast Implant (registration 80143600100), Natrelle Double Lumen Textured Breast Implant and Allergan Accessories (registration 80143600102). Technical Name: Tissue Expander (registration 80143600096), Breast Prostheses (registrations 80143600100 and 80143600102). ANVISA registration number: 80143600096, 80143600100, 80143600102. Risk Class: III Affected model: All models and lots referring to products registered under numbers 80143600100 and 80143600102. All models and lots as of 07/25/2014 for the product registered under number 80143600096, as stated in Resolution RE No. 2,037, of July 25, 2019. |
| 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 | 80143600096, 80143600100, 80143600102, 2.037 |
| Date | Jul 25, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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