Events

Alerte De Sécurité sur Trade name: GRAFTYS BCP Technical name: ENZYME OSSEO ANVISA registration number: 80517190002 Hazard class: I Target affected: Not applicable

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2205
  • Date
    2017-02-09
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    NO PATIENT ALERTING IS NECESSARY. HISTORICALLY WE HAVE NO ADVERSE EFFECT OR ANY KIND OF NOTICE FROM CUSTOMERS OR MEDICAL PROFESSIONALS ABOUT THE FAILURE OF GRAFTYS HBS AND GRAFTYS BCP PRODUCTS USED.
  • Cause
    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 BCP Technical name: ENZYME OSSEO ANVISA registration number: 80517190002 Haza...

Manufacturer

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