International safety notice
Alert 2206 (Technosurveillance) Update Announcement from the company Eurosilicone Round Collection breast implant Presence of particles - Resolution 3,548 of December 28, 2018 - Recall.
Brazil / Anvisa · BRA · Feb 20, 2017
Key facts
| Title | Alert 2206 (Technosurveillance) Update Announcement from the company Eurosilicone Round Collection breast implant Presence of particles - Resolution 3,548 of December 28, 2018 - Recall. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Product name: Round Collection. Technical name: Breast Implant. Registration: 80674930007. Product type: Material. Risk Class: III. Models ES.80, ES.801, ES.81, ES.811, ES.805N, ES.802N, ES.812N and ES810N. Lots: 157017; Access the Technovigilance Panels through the link https://www.gov.br/anvisa/pt-br/acessoainformacao/dadosabertos/informacoes-analiticas/tecnovigilancia and the full content of Alert 2206 with the respective attachments on the ANVISA website (https ://www.gov.br/anvisa/pt-br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA GCA BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA DESDE 2020 CNPJ 11015655000150 ENDEREÇO RUA PARANÁ Nº 107 SALA 27 E 2º ANDAR CHÁCARA DO SOLAR I FAZENDINHA SANTANA DE PARNAÍBA SP FABRICANTE EUROSILICONE SAS ZI DE LA PEYROLIÈRE BP 68 84402 APT CÉDEX FRANÇA |
| Models | 167047, 167018, 167019, 157065, 157066, 167014, 157043, 157047, 167026, ES.80, 157026, 167016 and 72 more |
| Date | Feb 20, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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