Retiro De Equipo (Recall) de MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Tornier Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Tornier is informing users of the known risk potentially associated with over-expansion of the small-sized mopyc stem (ptr-s7) that can result in its postoperative fatigue fracture.Although the operating technique emphasises the fact that stem expansion should only be performed when rotation instability is observed in the shaft, tornier noticed that the stems which were subject to fracture were over-expanded. tornier is providing users with a surgical technique addendum to emphasise this key point of the operating technique and to avoid unnecessary stem expansion that may be harmful for the patient.
  • Acción
    Tornier is providing users with a Surgical Technique Addendum to include further information regarding the risks of over expansion. This action has been closed-out on 25/08/2016.


  • Modelo / Serial
    MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)All batches manufactured since 2011ARTG Number: 94231
  • Manufacturer