Events

Alerte De Sécurité sur 1.SUBTON VTP VERTEBRAL BODY PUNCTURE CELL FOR VERTEBROPLASTY AND BIOPSY - REG. I SUSPEND 80038749001 ;. 2. SUBITON HQ SPLITTER - WITHOUT REGISTRATION ;. 3. SUBITON KNEE KNIFE - WITHOUT REGISTRATION; 4.MAXILOFACIAL - NO REGISTRATION; 5. RADIO-OPACO BONE CASE OF MANUAL APPLICATION - WITHOUT REGISTRATION ;. 6. BASS VISCOSITY STERILE RADIO-OPAQUE BONE CEMENT FOR APPLICATION WITH SYRINGE - WITHOUT REGISTRATION; 7. MANUAL APPLICATION RADIO-OPAQUE BONE CELL - WITHOUT REGISTRATION ;. 8.SUBITON HEMOSCTOR - REG. I SUSPEND 80038740001 ;. 9.SERINGA SUBITON GUN - REG. I SUSPEND 80038749004 ;. 10.SUBIMIX VTP - SUSPENDED REGISTRATION 80038749002 ;. 11.SUBITON BOWL - SUSPENDED REGISTRATION 80038749003 ;. 12.SUBIMIX V - SUSPENDED REGISTRATION 80038749005.

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 Angioline Ltda.

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
    1209
  • Date
    2012-12-04
  • 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
    See the full text of Resolution - RE Nº 4851, of 12/11/2012, published in the Official Gazette of the Union No. 219 - Section 1, of 13/11/2012 at http://www.in.gov.br/visualiza/index. .jsp? data = 13/11/2012 & journal; = 1 & page; = 127 & total Files = 232.
  • Cause
    All imported products requested by angioline ltda. (cnpj 02.305.681 / 0001-21), had their registrations independed at anvisa, because the company did not have the import activity in its business operation authorization (afe). in this way, anvisa determined as a measure of health interest: (i). the suspension, throughout the national territory, of the importation, dissemination, distribution, sale and use of all lots of all products imported by angioline ltda. - cnpj: 02.305.681 / 0001-21, as they are not registered with anvisa; and (ii). the collection of all units of the products mentioned in item (i) on the market.
  • Action
    The company must collect all lots of all products.

Device

1.SUBTON VTP VERTEBRAL BODY PUNCTURE CELL FOR VERTEBROPLASTY AND BIOPSY - REG. I SUSPEND 80038749...

Manufacturer

Angioline Ltda
  • Source
    ANVSANVISA