Events

Retiro De Equipo (Recall) de Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty Ltd.

¿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
    RC-2016-RN-01114-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01114-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    For a small portion of the affected lot, the seal between the top and base rollstock material of the product packaging may not have been manufactured correctly resulting in a sterile barrier breach. due to this breach in sterility, there is a potential for a bone or soft tissue infection which may require medical or surgical intervention.
  • Acción
    Stryker is advising users to inspect inventory for the affected lots and quarantine immediately. Affected stock can be returned to Stryker for replacement with unaffected product. This action has been closed-out on 10/05/2017.

Device

Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tis...
  • Modelo / Serial
    Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures)Item Number: 6118-097-090Lot Number: 16029017ARTG Number: 140542
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA