International safety notice
Alert 2819 (Technosurveillance) Arthrex do Brasil Shaver Blades and Coolcut Drills for Arthroscopic Surgery Possibility of generating excessive heat during use.
Brazil / Anvisa · BRA · Mar 18, 2019
Key facts
| Title | Alert 2819 (Technosurveillance) Arthrex do Brasil Shaver Blades and Coolcut Drills for Arthroscopic Surgery Possibility of generating excessive heat during use. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Shaver Blades and Coolcut Drills for Arthroscopic Surgery Technical Name: 1551621 - Surgical instruments ANVISA registration number: 80978560053 Risk Class: II Affected Model: AR-8550OBT - Oval Burr, 12 Flute, 5.5mm Affected serial numbers: Lots 10211276 and 10202784 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ARTHREX DO BRASIL IMPORTAÇÃO E COMERCIO DE EQUIPAMENTOS MÉDICOS LTDA CNPJ 18272616000187 RUA DELEGADO MORAES NOVAES 196 VILA ANDRADE SÃO PAULOSP CEP 05718310 SÃO PAULO SP TEL 11 4130 8950 EMAIL CAROLINARAMALHOARTHREXCOM FABRICANTE DO PRODUTO ARTHREX INC 1370 CREEKSIDE BOULEVARD NAPLES FLORIDA 34108 ESTADOS UNIDOS DA AMÉRICA |
| Models | AR-8550OBT, 1551621, 10211276, 10202784, 80978560053 |
| Date | Mar 18, 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