Events

Retiro De Equipo (Recall) de Smith & Nephew Echelon Hip System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Smith & Nephew Inc.

¿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
  • ID del evento
    16672
  • Fecha de inicio del evento
    2014-05-08
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Causa
    Smith & nephew surgical pty ltd has reported seven (n=7) medical device incident reports (mdir) of femoral stem component breakages. in all cases, the results of smith & nephew's investigations cited poor proximal bone support as a possible cause of implant failure., as a result of these investigations and smith & nephew's health hazard evaluation of this failure mode, the echelon surgical technique has been revised to reflect advice provided in the device instructions for use (ifu).
  • Acción
    Instructions for use to be updated

Device

Smith & Nephew Echelon Hip System

Manufacturer

Smith & Nephew Inc