International safety notice
Alert 2808 (Technovigilance) - Links - Plateau Component - Incorrect information on the labels of specific batches of the product.
Brazil / Anvisa · BRA · Mar 11, 2019
Key facts
| Title | Alert 2808 (Technovigilance) - Links - Plateau Component - Incorrect information on the labels of specific batches of the product. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Plateau Component Technical Name: Fixed joint insert for knee arthroplasty ANVISA registration number: 10417940041 Risk Class: III Affected model: 04.17.02.03009 Affected batch numbers: 20236T - NF N° 132616; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO VINCULA 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 | 132781, 04.17.02.03009, 10417940041, 20236T, 132782, 132616 |
| Date | Mar 11, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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