Events

Retiro De Equipo (Recall) de Distraction Screws Packaged sterile(Orthopaedic bone screw)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-01575-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-05
  • 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-01575-1
  • 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
    Between 1 july 2011 and 30 june 2016, the manufacturer has received 14 reports from customers in the usa of corrosion being evident on screws as they are removed from the immediate packaging. in australia, no reports of this issue have been received by bd. while no cases have been reported, degradation products of metal corrosion can result in inflammatory response locally and/or systemically. the elderly, pregnant, critically ill and immune-compromised patients may, however, be at greater risk if failure were to occur.
  • Acción
    Customers are advised to immediately quarantine any remaining stock. They will be contacted to arrange return of the quarantined stock.

Device

Distraction Screws Packaged sterile(Orthopaedic bone screw)
  • Modelo / Serial
    Distraction Screws Packaged sterile(Orthopaedic bone screw)Models: S-0088, S-0089, S-0090 & S-0091All lot numbers that are still within their labelled 5 shelf life ARTG Number: 263050
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd