International safety notice
Alert 2828 2nd Update (Technosurveillance) Víncula Industria Comércio Importação e Exportação de Implantes S.A. Plateau Component Possibility of difficulty fitting during implementation.
Brazil / Anvisa · BRA · Mar 21, 2019
Key facts
| Title | Alert 2828 2nd Update (Technosurveillance) Víncula Industria Comércio Importação e Exportação de Implantes S.A. Plateau Component Possibility of difficulty fitting during implementation. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Platô Component. Technical Name: Fixed Joint Insert for Knee Arthroplasty. ANVISA registration number: 10417940041. Product Type: Material. Risk Class: III. Affected model: 04.17.02.02010; Affected batch numbers: 18338T, 06933T, 15197T, 01052U, 12340T, 08976S, 18678T and 03615U. Update to Alert 2828: affected models and batch numbers have been updated. Access the full content of Alert 2828 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO VÍNCULA INDUSTRIA COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES SA CNPJ 01025974000192 AVENIDA BRASIL 2983 DISTRITO INDUSTRIAL RIO CLARO SP TEL 19 21116500 EMAIL RODRIGOBOTELHOVINCULACOMBR FABRICANTE DO PRODUTO VINCULA INDUSTRIA COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO DE IMPLANTES SA AVENIDA BRASIL 2983 DISTRITO INDUSTRIAL BRASIL |
| Models | 04.17.02.02010, 15197T, 04.17.02.02015, 08976S, 18678T, 04.17.02.04010, 04.17.02.04012, 06933T, 03615U, 01052U, 18338T, 10417940041 and 4 more |
| Date | Mar 21, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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.
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