Events

Retiro De Equipo (Recall) de Mako RIO System Irrigation Clip (partial knee application only)

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-2018-RN-00725-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-19
  • 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-2018-RN-00725-1
  • 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
    Stryker has discovered that specific lots of the mako rio system irrigation clip have the potential to fracture. the rio system irrigation clip is a sterile disposable, used to direct saline flow for the burring tool during a mako partial knee surgery. in the event of a break in the mako rio system irrigation clip, potential hazards of a fractured device and/or foreign object (inert particulate left in wound) may occur.
  • Acción
    Stryker is advising customers to inspect inventory and quarantine affected product, Stryker will contact customers to arrange return of affected product.

Device

Mako RIO System Irrigation Clip (partial knee application only)
  • Modelo / Serial
    Mako RIO System Irrigation Clip (partial knee application only)Catalogue Number: 111690Lot Numbers: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643 and 195763A1ARTG Number: 223929
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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