Events

Safety Alert for Trade name: SILICONES DE ADICAO AQUASIL. ANVISA registration number: 8019688020. Risk class: I - Low Risk. Model Affected: AQU ASI L EASY M IX PUTW. Lot number affected: 150629

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Dentsply Indústria e Comércio Ltda.; DENTSPLY CAULK.

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
    1919
  • Date
    2016-05-12
  • 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
    Customers who have purchased the product must preemptively store it and contact Dentsply for free replacement. Phone: (24) 2233-1818 - rnartelle.cortezia@dentsplysirona.com
  • Reason
    The product silicones de adicao aquasil, presented a change in working time and prey of lot 150629. the problem was detected by the manufacturer through investigation of two complaints and the causes are being investigated through capa by the manufacturer. the user, when using the product, will find a change in working time and prey, resulting in an interference with the quality of the molding, leading to dissatisfaction.
  • Action
    Collection and destruction by the company holding the registration. Code 2. Letter to the clients in annex.

Device

Trade name: SILICONES DE ADICAO AQUASIL. ANVISA registration number: 8019688020. Risk class: I - ...

Manufacturer

Dentsply Indústria e Comércio Ltda.; DENTSPLY CAULK