International safety notice
Alert 2732 (Technovigilance) - Intermedic Importação e Exportação Ltda - Family of Discs for Cranial Fixation Rapidflap - Possibility of incorrect connection in the nut that interfaces with the product's external plate.
Brazil / Anvisa · BRA · Nov 13, 2018
Key facts
| Title | Alert 2732 (Technovigilance) - Intermedic Importação e Exportação Ltda - Family of Discs for Cranial Fixation Rapidflap - Possibility of incorrect connection in the nut that interfaces with the product's external plate. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Family of Discs for Cranial Fixation - Rapidflap Technical Name: Halo-Cranial Fixation Implant ANVISA registration number: 80094170099 Risk Class: IV Affected model: Rapidflap 16mm Skull Closure System - 75-1030 Affected serial numbers: 665160 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO INTERMEDIC IMPORTAÇÃO E EXPORTAÇÃO LTDA CNPJ 01390500000140 RUA DOUTOR FERNANDES COELHO 64 CONJ 5152 PINHEIROS SÃO PAULO SP TEL 11 35032030 EMAIL PRISCILASILVEIRAINTERMEDICCOMBR FABRICANTE DO PRODUTO BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE FLORIDA ESTADOS UNIDOS DA AMÉRICA |
| Models | 75-1030, 665160, 80094170099 |
| Date | Nov 13, 2018 |
| 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