Events

Alerta De Seguridad para Prosthesis System for Articular Replacements

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 N/A.

¿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
    R1709-459
  • Número del evento
    2014DM-0011287
  • Fecha
    2017-09-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=71
  • 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

Prosthesis System for Articular Replacements
  • Modelo / Serial
    IMP74115, lot 012154004000
  • Descripción del producto
    The prosthesis system for joint replacements and its associated instruments C2F is designed for the partial or total artificial replacement of the joints of the body and indicated for the treatment of joint complexes, osteoarthritis, joint instabilities. Allowing to restore mobility, correct joint deformities, joint reconstruction, with specific clinical indications according to articulation and reference. Prostheses for hip replacement of the prosthesis system for joint replacements and their associated instruments C2F, have other indications:? In case of pain due to the articulated joint destruction resulting from degenerative, inflammatory or post-traumatic pathology, or to the resulting effects after a trauma, or to the failure of previous operations. ? For first or secondintention surgery. ? Avascular necrosis. ? Traumatic arthritis ? Degenerative inflammatory disease of the joints including rheumatoid arthritis, arthritis secondary to a variety of diseases and abnormalities, and congenital dysplasia among other indications for use, prostheses for knee replacement of the prosthesis system for joint replacements and its associated instruments c2f®, for the treatment of:? Rheumatoid arthritis ? Post-traumatic arthritis, laosteoarthritis or degenerative arthritis. ? Failed osteotomies? Advanced articular destruction resulting from degenerative, inflammatory opost-traumatic pathology? Surgery of first intention, in the primary gonarthrosis associated to: important axial deviation, important laxity or important rigidity. ? Revision surgery of knee prostheses that have been found, in particular, in the case of a second recurrence of axial deviation, abnormal laxity or severe rigidity.
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA