Retiro De Equipo (Recall) de Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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
    Depuysynthes reported that the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly as follows: - failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area, in which excess rotational forces could cause breakage- use of ria drive shafts after the flats have become worn and rounded - use of any excess force beyond design limit - use with an incompatible power tool. precautionary statements are being added to the reamer / irrigator / aspirator (ria) surgical technique guide.
  • Acción
    DePuySynthes is requesting the customers to download the updated Surgical Technique Guide (036.000.553). from Synthes website at:- or contact their DePuy Synthes Representative for a hardcopy. This action has been closed-out on 05/12/2016.