Events

Alerte De Sécurité sur Angle Meter 17 degrees - Model 128017, lot 800069008, Registration No. 10344420037.

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
    1480
  • 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, when performing the surgical procedure for implant installation, the dentist will incorrectly measure the angulation of the perforation performed. Thus, the choice of component angulation will be performed incorrectly, which may compromise the inclination of the prosthesis and, consequently, its aesthetics and function, and it may be necessary to change the component and perform a new prosthesis.
  • Cause
    The record company informs that it has identified, through customer complaint, that the angulation information of the 17 degree angle meter product, recorded on parts of lot 800069008, is incorrect. recorded information: 30 degrees; correct information: 17 degrees.
  • Action
    The company that registers in Brazil advises dentists to check their inventories and, if they identify products from the lots that are the target of the field action, send them to Neodent.

Device

Angle Meter 17 degrees - Model 128017, lot 800069008, Registration No. 10344420037.

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.