Events

Retiro De Equipo (Recall) de Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure kit)

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-2013-RN-00114-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-07
  • 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-2013-RN-00114-1
  • 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
    Preliminary testing by stryker orthopaedics indicates that some silicone suction cup sub-component were manufactured from a non-silicone polymer, polyvinyl chloride (pvc) and that these pvc cups contain latex.
  • Acción
    Stryker is requesting customers to identify and remove any affected stock until the units can be collected or returned to Stryker

Device

Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure ...
  • Modelo / Serial
    Ceramic Insertion Tool Assembly (Supplied as part of the reusable orthopaedic surgical procedure kit)Catalogue number: 2216-0005All lot numbers are affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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