Events

Retiro De Equipo (Recall) de Stryker Medical - Performance Load

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 Stryker Medical.

¿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
    22766
  • Fecha de inicio del evento
    2018-04-03
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    After installation of the power-load, the floor plate attachment brackets (pn: 6390-101-108) which allow the power-load anchor to be secured to the power-load floor plate may be found to be broken after removing the anchor. all power-load units manufactured from january 1, 2016 to december 31, 2016, may potentially exhibit this issue.
  • Acción
    Manufacturer to issue advice regarding use

Device

Stryker Medical - Performance Load
  • Modelo / Serial
    Model: , Affected: All serial numbers beginning with 16 are within scope of this action e.g. 160139706
  • Manufacturer
    Stryker Medical

Manufacturer

Stryker Medical
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA