Events

Safety Alert for Trade name: PROTESE FOR KNEAD ARTHROPLASTY. Risk Class: III - HIGH RISK. Record Number: 10171110029. Validity: Registered Standards: December 22, 2014

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMECÂNICA INDÚSTRIA E COMÉRCIO DE PRODUTOS ORTOPÉDICOS LTDA.

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
    1264
  • Date
    2013-06-03
  • 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
    In November 2013 the company announced the completion of the Field Action
  • Reason
    Suspension of distribution, marketing and implants, as well as the collection of the product protese for knee arthroplasty - registration 10171110029. based on the results of the inspection performed at the company to verify the good practices in the manufacture of medical products, the result of which was evaluated risk and regularity of registration of the products, sanitary measures were adopted expressly by the resolution re 1908, of 05/28/2013. said resolution re 1908/2013 was published in dou no. 102 - section 1 - page 91, of 05/29/2013 (see annex).
  • Action
    The National Health Surveillance Agency (ANVISA) has determined, as a measure of health interest, the suspension throughout the national territory of distribution, marketing and implants, as well as the collection of the remaining units on the market related to the identified product codes in Resolution RE 1908 of 05/28/2013.

Device

Trade name: PROTESE FOR KNEAD ARTHROPLASTY. Risk Class: III - HIGH RISK. Record Number: 101711100...

Manufacturer

BIOMECÂNICA INDÚSTRIA E COMÉRCIO DE PRODUTOS ORTOPÉDICOS LTDA