Events

Retiro De Equipo (Recall) de Midas Rex Classic, GS and Legend

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Medtronic France.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2005-09-12
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-d-outils-de-dissection-midas-rex-classic-gs-et-legend-medtronic
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    MEDTRONIC Powered Surgical Solutions has withdrawn from the market on September 8, 2005, the batches manufactured before April 2004, medical devices called "disposable dissection tools (strawberries) single-use Midas Rex Classic, GS and Legend" following the risk of packaging brittle observed after 30 months of expiry; as a result, all lots older than 18 months, ie with an expiry date from September 2005 to March 2009, are withdrawn from the market. The company has directly notified the recipients of the incriminated lots using of the message attached (08/09/2005) (47 KB) validated by Afssaps .. For the products not concerned by the recall, the expiry time has been reduced to 30 months and the batch number has been underlined to identify them .. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Midas Rex Classic, GS and Legend
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Medtronic France

Manufacturer

Medtronic France
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    LAANSM