Events

Retiro De Equipo (Recall) de Scorpio Patella Clamp (used to hold the patella in place during the cementing process)

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-01063-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-10
  • 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-01063-1
  • 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 orthopaedics has received four reports of disassociated components of the scorpio patella clamp. an investigation revealed that the press-fit specifications between the pins and either one or both clamping subcomponents were not met. no adverse patient consequences were reported. the instrument components, including pins and clamping subcomponents may potentially disassociate and fall into the wound intra-operatively, necessitating retrieval. as such, the potential harms may include: - complications associated with extended surgery time - inflammatory response - tissue damage - revision surgery to retrieve loose components.
  • Acción
    Stryker is advising users to inspect stock and quarantine the whole tray immediately if the affected product is found. A Stryker representative will coordinate a replacement clamp or the return of the whole tray that the affected item is in and provide access to unaffected trays as required. This action has been closed-out on 18/05/2017.

Device

Scorpio Patella Clamp (used to hold the patella in place during the cementing process)
  • Modelo / Serial
    Scorpio Patella Clamp (used to hold the patella in place during the cementing process)Item Number: 3182-1000Tray Item Numbers: 31821000-T, 33023024-T, 80002017-T, 80106661-T, 8200TSX-TMultiple Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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