Retiro De Equipo (Recall) de Wright Medical Claw and Claw II plates

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 Wright Medical Technology 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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: Surgical Specialities (NZ) Limited, 4B Ride Way, Albany, AUCKLAND 0632
  • Causa
    It has been identified that the stainless steel used in claw and claw ii plates from the affected lots did not meet the manufacturing requirements, resulting in reduced strength and increased risk of warping under stress. if this occurs, the device could fail., if this problem occurred during surgery, it would be corrected immediately. however, surgery time would be increased., if an affected device has been implanted and did not fail during surgery, there is a remote possibility that it could fail before fusion of the bones occurs. if this happens, revision surgery will be required.
  • Acción
    Product to be returned to supplier