International safety notice
Alert 2879 (Technovigilance) - BR Implants - XTremities Easylock System for Small Fragments Unsatisfactory results in the microbiological control carried out by the manufacturer.
Brazil / Anvisa · BRA · May 15, 2019
Key facts
| Title | Alert 2879 (Technovigilance) - BR Implants - XTremities Easylock System for Small Fragments Unsatisfactory results in the microbiological control carried out by the manufacturer. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: XTremities Easylock Small Fragment System Technical Name: Rigid fixation system for special plates for osteosynthesis ANVISA registration number: 80261100014 Risk Class: III Affected model: PE120201; Affected serial numbers: All |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BR IMPLANTES COMÉRCIO DE MATERIAIS CIRÚRGICOS LTDA CNPJ 07088722000199 RUA LEVI COELHO 43 SLS 101104 BELO HORIZONTE MINAS GERAIS TEL 31 32414174 EMAIL VINICIUSVGBRASCOMBR FABRICANTE DO PRODUTO TORNIER SAS 161 RUE LAVOISIER 38330 MONTBONNOT SAINT MARTIN FRANÇA |
| Models | 80261100014, PE120501, PE120601, PE120203, PE120201, PE120202 |
| Date | May 15, 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.
Source: National medical device regulators (as listed), compiled by Orca1