Events

Safety Alert for DENTAL IMPLANTS - Model 140692 IMPLANT DRIVE CM 3.5 X 8.0 ACQUA, Registration nº 10344420072 - Lote- 800170628

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
    1541
  • Date
    2015-02-23
  • 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 professional has not observed the failure prior to the surgical procedure or observes during its accomplishment and does not have another unit of item 140.692 for replacement, the conclusion of the surgery to implant the implant may be unfeasible, compromising the aesthetic and functional reestablishment of the patient.
  • Reason
    The company that holds the registration informs about the absence of the implant in the product packaging, lot 800170628, item 140.692.
  • Action
    The company that registers in Brazil advises dental surgeons to entrust their inventories and forward the units of nonconforming product to Neodent.

Device

DENTAL IMPLANTS - Model 140692 IMPLANT DRIVE CM 3.5 X 8.0 ACQUA, Registration nº 10344420072 - Lo...

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.