Events

Retiro De Equipo (Recall) de 5mm Round Fluted Bur Aggressive, Round Fluted Soft Touch 3.0mm, Round Fluted Bur 6.0mm, 3mm Round Fluted Bur Aggressive, Neuro Drill 3.0mm, 6mm Round Fluted Bur Aggressive, Round Fluted Bur 1.0mm and 5.0mm Egg Bur (Orthopaedic bur used for soft tissue debridement and bone abrasion and removal)

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-2014-RN-00593-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-30
  • 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-2014-RN-00593-1
  • 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
    During manufacture, the notching completed on one specific machine may have been started too close to the end of the shank. in some products (approximately 1/1000), there may be missing notches, partial notches or no notches at all. the listed cutting accessories are manufactured with notches at the proximal end of the bur. the notch is a feature on the bur that is used to retain and control the exposure of the bur within the drill/attachment. the correct number of notches varies from 2 to 5, based on the specific product number.
  • Acción
    Stryker is requesting their customers to quarantine all affected stock and advising that they will be contacted to organize for the return of the product.

Device

5mm Round Fluted Bur Aggressive, Round Fluted Soft Touch 3.0mm, Round Fluted Bur 6.0mm, 3mm Round...
  • Modelo / Serial
    5mm Round Fluted Bur Aggressive, Round Fluted Soft Touch 3.0mm, Round Fluted Bur 6.0mm, 3mm Round Fluted Bur Aggressive, Neuro Drill 3.0mm, 6mm Round Fluted Bur Aggressive, Round Fluted Bur 1.0mm and 5.0mm Egg Bur (Orthopaedic bur used for soft tissue debridement and bone abrasion and removal)Multiple item numbers and lot numbers affected
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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