Events

Retiro De Equipo (Recall) de Stryker System 6 Aseptic Battery Kit, aseptic housing

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 Instruments.

¿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
    17999
  • Fecha de inicio del evento
    2015-01-21
  • 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 manufacturer has identified the above lot to have insufficient bond strength at a weld joint. therefore, the quality of the weld may not be as effective as intended. this could lead to the separation of the top section of the housing from the bottom section.
  • Acción
    Product to be returned to supplier

Device

Stryker System 6 Aseptic Battery Kit, aseptic housing
  • Modelo / Serial
    Model: Catalogue: 6126-120-000, Affected: Lot Numbers: 13205 (kit) & 1312, 13210, 13209 (housings)
  • Manufacturer
    Stryker Instruments

Manufacturer

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