Events

Safety Alert for ADJUSTER FOR CONNECTION CABINET FOR ANGLE - Model 105025, lots: 800116982, 800116984 and 800116985, Registration No. 10344420026

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
    1479
  • Date
    2014-11-28
  • 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, if the dentist does not notice the instability in the socket and insists on installing the mini-implant, it may deform or fracture the same.
  • Reason
    The company holding the registration informs that it has identified, from customer complaint, that batches 800116982, 800116984 and 800116985 of the product for counter-angle connections ratchet adapter do not have the inner ring.
  • 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

ADJUSTER FOR CONNECTION CABINET FOR ANGLE - Model 105025, lots: 800116982, 800116984 and 80011698...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.