Events

Alerta De Seguridad para Articular Prosthesis and its Associated Instrument

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Synthes Gmbh.

¿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
    I1804-239
  • Número del evento
    2009DM-0003101
  • Fecha
    2018-04-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=50
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data

Device

Articular Prosthesis and its Associated Instrument
  • Modelo / Serial
    Epoca revision set and its stem extractors
  • Descripción del producto
    EPOCA is a modular system of joint prostheses and associated instrumental specific and indispensable for the placement of such prostheses destined for the total, partial replacement or reconstruction of shoulder articulation and is indicated for: advanced destruction resulting from rheumatoid or post-traumatic or degenerative arthritis of the shoulder joint ; avascular necrosis; fractures in the shoulder joint; failure of previous surgery such as osteosynthesis, reconstruction of the joint or arthroplasty of the shoulder joint; reconstruction of the humeral portion of the shoulder joint by severe damage and / or disabled by rheumatoid arthritis, traumatic or necrosisavascular arthritis where radiographic evidence of sufficient bone tissue to support the prosthesis is found.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh