Events

Alerte De Sécurité sur PEEK intersomatic device, phospho-calcic ceramic bone graft and fusion tube

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 Bio Engenharia e Indústria de Implantes Ortopédicos.

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
    760
  • Date
    2003-12-23
  • 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
    considering the provisions of paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the provisions of items IV and XXXV of Article 10, of Law No. 6.437, of August 20, 1977; considering the provisions of Arts. 12 of Law 6,360 / 76, of September 23, 1976; Considering the provisions of art. 1 of the DRC, 59 of June 27, 2003; considering the Oficio n ° 731/2003-SMC / DVS of the Secretary of State of Health of Rio Grande do Sul, forwarding the inspection report held at the Bio Engineering and Industry of Orthopedic Implants, the Notice of Infringement No. 021 / 03, Interim injunction No 007/2003 concerning the prohibition of the company for not having Good Manufacturing Practices and for manufacturing the products PEEK intersomatic device, bone graft type phospho-calcic ceramic and fusion tube without registration with Anvisa.
  • Cause
    Do not have good manufacturing practices and for manufacturing products without registration with anvisa.
  • Action
    Interdiction of the company for not having Good Manufacturing Practices and for manufacturing the products intersomatic device PEEK, bone graft type phospho-calcic ceramic and fusion tube without registration with Anvisa

Device

PEEK intersomatic device, phospho-calcic ceramic bone graft and fusion tube

Manufacturer

Bio Engenharia e Indústria de Implantes Ortopédicos
  • Source
    ANVSANVISA