Events

Alerte De Sécurité sur Implant Titamax Ti Cortical (4.1) 4.0x13 - lot: 800098936, Registration nº 10344420031

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 JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A..

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
    1481
  • Date
    2014-11-28
  • 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
    According to the manifestation of the company, if the dentist has a unit that is not compliant, it can not complete the installation of the implant, since it would be trapped in the packing ring. If the dentist can remove the implant from the package, there is no risk of its use, since the implant is in accordance with the specifications.
  • Cause
    The company holding the registration informs that it has been identified, after customer complaint, that some packages of the titamax ti cortical (4.1) 4.0x13 implant received the upper ring, which supports the implant inside the package, of a size smaller than specified. in this way, the implants contained in these packages remain attached to the ring.
  • Action
    The company that registers in Brazil advises dental surgeons to check their inventories and, if they identify products from the field action lot, send them to Neodent.

Device

Implant Titamax Ti Cortical (4.1) 4.0x13 - lot: 800098936, Registration nº 10344420031

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.