International safety notice
Alert 2697 (Technovigilance) - Intermedic Importação e Exportação Ltda - Instrumental Kit for Intramedullary Nail - Biomet Trauma - Possibility of reducing the fatigue resistance of the screw connector, which can lead to fracture.
Brazil / Anvisa · BRA · Oct 11, 2018
Key facts
| Title | Alert 2697 (Technovigilance) - Intermedic Importação e Exportação Ltda - Instrumental Kit for Intramedullary Nail - Biomet Trauma - Possibility of reducing the fatigue resistance of the screw connector, which can lead to fracture. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Instrumental Kit for Intramedullary Nail - Biomet Trauma Technical Name: Instrumental Kit ANVISA registration number: 80094170040 Risk Class: I Affected model: Screw Connector. Affected serial numbers: 740620; |
| 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 MANUFACTURING LLC BIOMET TRAUMA WARSAW 56 EAST BELL DRIVE PO BOX 587 WARSAW IN ESTADOS UNIDOS DA AMÉRICA |
| Models | 80094170040, 324761, 740620 |
| Date | Oct 11, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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