Events

Retiro De Equipo (Recall) de Stryker SBi u head stem and sigmoid notch radial stem

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 Small Bone Innovations 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
    18724
  • Fecha de inicio del evento
    2015-06-24
  • 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
    Stryker became aware during laboratory testing that there is a potential that the packaging integrity (sterile barrier) of the packaging type kit i may be compromised by transportation. a compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognized, an unintended implantation of a potentially non sterile device. the packaging type kit i consists of a white cardboard box, an outer peel pouch, and an inner peel pouch.
  • Acción
    Manufacturer to issue advice regarding use

Device

Stryker SBi u head stem and sigmoid notch radial stem

Manufacturer

Small Bone Innovations Inc
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA