Events

Retiro De Equipo (Recall) de Stryker OtisMed Shapematch Cutting Guides

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 Howmedica Osteonics.

¿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
    15262
  • Fecha de inicio del evento
    2013-09-02
  • 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
    The reason for this hazard alert is multifactorial:, , 1/ the surgical protocol for the shapematch cutting guides did not provide sufficient information on:, the position of the cutting guides,, the need for osteophyte/soft tissue removal,, the requirement for proper axial drilling and, the need to avoid angulation and mal-alignment., , 2/ the approved pre-operative plan did not provide sufficient information regarding the need for osteophyte removal., , 3/ the values displayed via the otismed.Net web portal were inconsistent with the pre-operative planning values used to manufacture some of the shapematch cutting guides.
  • Acción
    Manufacturer to issue advice regarding use

Device

Stryker OtisMed Shapematch Cutting Guides

Manufacturer

Stryker Howmedica Osteonics
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA