Events

Safety Alert for Implant Titamax Ti EX (4.1) 3.75x13 - lot 800080809 and Implant Titamax Ti Cortical (5.0) 5.0x9 - lot: 800080529, 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
    1396
  • Date
    2014-06-06
  • 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 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.
  • Reason
    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.