Events

Retiro De Equipo (Recall) de Stryker Shape Arm Kit Left

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 Communications 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
    Recall
  • ID del evento
    16450
  • Fecha de inicio del evento
    2014-03-25
  • 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
    Manufacturer has become aware that there is a remote likelihood of the lock washer and screw that secures the monitor onto the shape arm not to be present. if not present the monitor could separate and dislodge from the arm potentially resulting in injury., the shape arm is an articulating arm for the boom system. it is intended for the mounting/ positioning of a flat panel monitor that is used to view/ perform surgery. the monitor is attached to the shape arm by standard vesa/ tilter bracket that is installed onto the shape arm and is secured with a lock washer and screw., the shape arm does not sustain or support life.
  • Acción
    Product to be modified

Device

Stryker Shape Arm Kit Left

Manufacturer

Stryker Communications Inc
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA