Events

Safety Alert for Implant Titamax Ti Cortical (4.1) 3.75X11 - Model 109285 - lot: 800095526, Registration nº 10344420031

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1491
  • Date
    2014-12-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    The company holding the registration informs that it has been identified, after customer complaint, that some packages of the titamax ti cortical (4.1) 3.75x11 implant have 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) 3.75X11 - Model 109285 - lot: 800095526, Registration nº 103444...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.