Events

Safety Alert for Trade name: GRAFTYS HBS Technical name: OSSEO ENZYME Registration number ANVISA: 80517190001 Hazard class: III Affected model: GYHBSV1Q5, GYHBSV1Q8, GYHBSV1Q16

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2196
  • Date
    2017-02-09
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Due publication of resolution re n ° 325 of february 7, 2017, anvisa determined, as a measure of health interest, in all national territory, article 1, suspension of imports, distribution, marketing and use of graftys hbs and graftys products bcp, imported by the company latim american solutions improtação e exportação ltda, cnpj 09.183.319 / 0001-74, considering the conclusion of the unsatisfactory international inspection report for the graftys sarl manufacturing company of these products, whereas most non-conformities found related directly with the products. in article 2 of this same resolution it has been determined that latin american solutions importação e exportação ltda carries the collection of graftys hbs and graftys bcp products in any national territory. the company will make measures for the pickup to be performed and for the compliance of the suspension.
  • Action
    Field Action Code 01 2017 triggered under the responsibility of the company LAS - LATTIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company will collect.

Device

Trade name: GRAFTYS HBS Technical name: OSSEO ENZYME Registration number ANVISA: 80517190001 Haza...

Manufacturer

LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL
  • Source
    ANVSANVISA