Events

Alerte De Sécurité sur Implant Titamax Ti EX (4.1) 3.75x13 - lot 800080809 and Implant Titamax Ti Cortical (5.0) 5.0x9 - lot: 800080529, 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
    1396
  • Date
    2014-06-06
  • 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 company's statement, the sales of the implants are performed according to the external label of the product, the dental surgeon would prepare to perform surgery for the installation of an implant Ti EX and could not finish the surgery for finding a Ti implant cortical instead. Could not finish the surgery by having an implant for different purpose and size divergent than expected.
  • Cause
    The company that owns the registration reports a failure in the labeling process, and some units of the titamax ti cortical implant (5.0) 5.0x9 received the external label of the titamax ti ex (4.1) 3.75x13 implant.
  • Action
    The company that registers in Brazil informs that its commercial advisers will visit the dentists who purchased this lot of the product to confirm if there was a failure in the labeling and to make the exchange and the collection of products with diversion.

Device

Implant Titamax Ti EX (4.1) 3.75x13 - lot 800080809 and Implant Titamax Ti Cortical (5.0) 5.0x9 -...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.