Events

Retiro De Equipo (Recall) de MatrixORTHOGNATHIC Screws; MatrixMANDIBLE Screws; MatrixMIDFACE; MatrixNEURO Screws (Non-sterile and sterile screws supplied as part of a craniofacial fixation plate 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 Synthes 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-00341-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-04-19
  • 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-2013-RN-00341-1
  • 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
    The affected screws are packaged in a "clip" that has a laser etch corresponding to the length of the screw. it has been reported that the etch on the clip does not correspond to the length of the screw. there have been instances in which the screw was longer than the specified etch, as well as the screw being shorter than the specified etch.
  • Acción
    Synthes is asking users to return affected products. If the screws must be used before replacements arrive, Synthes is asking users to measure them prior to use.

Device

MatrixORTHOGNATHIC Screws; MatrixMANDIBLE Screws; MatrixMIDFACE; MatrixNEURO Screws (Non-sterile ...
  • Modelo / Serial
    MatrixORTHOGNATHIC Screws; MatrixMANDIBLE Screws; MatrixMIDFACE; MatrixNEURO Screws (Non-sterile and sterile screws supplied as part of a craniofacial fixation plate kit)Multiple affected lot numbers and part numbersARTG Number: 157706
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd