Retiro De Equipo (Recall) de Helianthe Hip Resin Rods

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 Wright Medical Technology - EMEA.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    On March 31, 2008, Wright Medical Technology - EMEA withdrew from the market the batches of the references contained in the attached medical device message called Helianthe Hip Resin Rods, manufactured by Wright Medical Technology, Inc., continued a non-conformity of the rods to the manufacturing specifications regarding the anteroposterior width (A / P) of the proximal end of the rod. Indeed, these devices are slightly undersized at the thickest point of the proximal width. The company Wright Medical Technology - EMEA has directly notified the recipients of the offending lots with the enclosed message validated ( 02/04/2008) (78 ko) by Afssaps. This information is intended for surgeons for dissemination to the relevant services where applicable. The relevant European Competent Authorities are informed of this measure by the manufacturer.