Events

Alerte De Sécurité sur Prosthesis System for Articular Replacements

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1709-459
  • Numéro de l'événement
    2014DM-0011287
  • Date
    2017-09-29
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=71
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données

Device

Prosthesis System for Articular Replacements
  • Modèle / numéro de série
    IMP74115, lot 012154004000
  • Description du dispositif
    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