Events

Safety Alert for DISPOSABLE BONE SCRAPER - Model 1270 23, Registration nº 10344420036 - Batch- 800100492

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
    1390
  • Date
    2014-05-12
  • 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
    The problem verified leads to a failure in the efficacy of the product, and it is not possible to perform the surgery in an adequate manner and impairing the rehabilitation of the patient.
  • Reason
    The company that owns the registry informs that the bone scraper is failing to cut the blade.
  • Action
    The company that registers in Brazil informs that its commercial advisors will visit the dentists who purchased this lot of the product to exchange and collect products with diversion

Device

DISPOSABLE BONE SCRAPER - Model 1270 23, Registration nº 10344420036 - Batch- 800100492

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.