Events

Retiro De Equipo (Recall) de Rex Rehab

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 Rex Bionics Limited.

¿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
    20156
  • Fecha de inicio del evento
    2016-06-20
  • 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: Rex Bionics Limited, 58 Apollo Drive, Rosedale, Auckland 0751
  • Causa
    As part of the corrective and preventive action into an incident report, where a patient sustained an injury relating to incorrectly securing the heel stops on the rex, the sponsor has issued a recall for product correction to:, 1. reinforce the instructions in the current ifu around the importance of correct heel stop adjustment, and, 2. add an additional statement to the ifu to specifically highlight the use of external supports (such as braces, splints, supports) which may restrict a user's range of motion and cause serious harm.
  • Acción
    Manufacturer to issue advice regarding use

Device

Rex Rehab

Manufacturer

Rex Bionics Limited
  • Source
    NZMMDSA