Events

Safety Alert for REG.10395270003-PROD.:About Charnley Incomepe. REG.10395270005-PROD.:Grain Total Prosthesis Type Charnley Incomepe. REG.10395270006-PROD.:Physical Partial Hip Type Thompson Incomepe. REG.10395270008-PROD.:Redpe Shoulder Prosthesis. REG.10395270012-PROD.:About Muller Incomepe. REG.10395270017-PROD.:Interchangeable Incomepe Head. REG.10395270022-PROD.:About Bipolar Incomepe. REG.10395270023-PROD.:Component Glenpoe Incomepe. REG.10395270026-PROD.:Interchangeable Head Neer II Incomepe. REG.10395270042-PROD.:INK Knee Prosthesis

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by INCOMEPE INDÚSTRIA DE MATERIAIS CIRURGICOS 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
    1231
  • Date
    2013-01-23
  • 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
    Company Unleashed Field Action.
  • Reason
    Non-compliance with anvisa's regulatory requirements.
  • Action
    ANVISA determined as a measure of sanitary interest, the suspension of distribution, trade, dissemination and implantation, throughout the national territory, of all lots of products ACETÁBULO DE CHARNLEY INCOMEPE, TOTAL PROSTHESIS OF CHARNLEY INCOMEPE TYPE HING, THOMPSON TYPICAL QUADRIL PROSTHESIS INCOMEPE, PROLESCENCE OF SHOULDER INCOMEPE, MULLER INCOMEPE ACETABLE, INTERCHANGEABLE HEAD INCOMEPE, BIPOLAR INCOMEPE ACETABLE, COMPONENT GLENÓIDEO INCOMEPE, INTERCHANGEABLE HEAD NEER II INCOMEPE and SINJ KNEE PROSTHESIS, manufactured by INCOMEPE INDÚSTRIA DE MATERIAIS CIRURGICOS LTDA, CNPJ 57.212.870 / 0001-41, located at Rua Um, Nº 35, Barro Branco, Cotia - SP, for failing to comply with ANVISA's regulatory requirements. It was also determined the collection of all remaining lots on the market, not implanted.

Device

REG.10395270003-PROD.:About Charnley Incomepe. REG.10395270005-PROD.:Grain Total Prosthesis Type ...

Manufacturer

INCOMEPE INDÚSTRIA DE MATERIAIS CIRURGICOS LTDA
  • Source
    ANVSANVISA