International safety notice

Alert 2822 (Technovigilance) - Ossis Medical Comércio Importação e Exportação S.A. - Avitus Bone Harvester Possibility of compromising the stability of a specific batch.

Brazil / Anvisa · BRA · Mar 19, 2019

Key facts

Title Alert 2822 (Technovigilance) - Ossis Medical Comércio Importação e Exportação S.A. - Avitus Bone Harvester Possibility of compromising the stability of a specific batch.
Regulator Brazil / Anvisa
Country BRA
Brand Commercial Name: Ancestor Bone Harvester Technical Name: Collectors ANVISA registration number: 80625390004 Risk Class: II Affected model: BH-110 Affected serial numbers: Z2458218A
Manufacturer EMPRESA DETENTORA DO REGISTRO OSSIS MEDICAL COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO SA CNPJ 10910549000177 RUA DOMINGOS LOPES DA SILVA 890 CJ 1305 SÃO PAULO SP TEL 11 43013714 EMAIL PRISCILAMASEOSSISCOMBR FABRICANTE DO PRODUTO AVITUS ORTHOPAEDICS INC 400 FARMINGTON AVE SUITE R2826 FARMINGTON CT 06032 ESTADOS UNIDOS
Models 80625390004, BH-110, Z2458218A
Date Mar 19, 2019
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

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