Events

Safety Alert for Trade name: Broca Esf. Diam. Hi-Line Great. Thick IT / Drill Esf. Diam. Hi-Line Great. Thick Tip Technical Name: Broca Esf. Diam. Hi-Line Great. Thick IT / Drill Esf. Diam. Hi-Line Great. Affected serial numbers: 51745118, 51649830, 51708484, 51838047, 51634741 and 51293170. Note: The unit of lot 51293170 was used during the disclosure project. of the product in 2005, and is not distributed to the customer.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A.; Aesculap AG.

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
    2267
  • Date
    2017-04-12
  • 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
    Interruption of the use of said lot numbers, segregation thereof and information to Laboratorios B. Braun SA, for collection.
  • Reason
    During surgery, the possibility of releasing particles from the diamond covering to the situs was observed, which may not be perceived by the user.
  • Action
    Field Action Code AC / 02/2017 triggered under the responsibility of the company Laboratorios B. Braun SA Company will collect for later return to the manufacturer.

Device

Trade name: Broca Esf. Diam. Hi-Line Great. Thick IT / Drill Esf. Diam. Hi-Line Great. Thick Tip ...

Manufacturer

Laboratórios B. Braun S.A.; Aesculap AG