Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por INCOMEPE INDÚSTRIA DE MATERIAIS CIRURGICOS LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1231
  • Fecha
    2013-01-23
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Company Unleashed Field Action.
  • Causa
    Non-compliance with anvisa's regulatory requirements.
  • Acción
    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.

Manufacturer