Events

Retiro De Equipo (Recall) de Tension Band Pins (Internal fixation pins)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical & Optical Instruments 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-00449-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-05-09
  • 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-00449-1
  • 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
    Specific lots of tension band pins manufactured between july 2009 and march 2011 are being recalled because they were manufactured with astm f138 stainless steel but should have been manufactured with astm a276 stainless steel. both standards are grade 316l stainless steel and contain the exact same chemical elements but in different concentrations. although the biocompatibility was only tested on astm f138 there is no evidence to indicate that astm a276 is not biocompatible.
  • Acción
    Medical + Optical is contacting their customers to arrange for the return of affected devices.

Device

Tension Band Pins (Internal fixation pins)
  • Modelo / Serial
    Tension Band Pins (Internal fixation pins)Part Numbers:TB-1550K-SLot Number: 223007TB-1570K-SLot Numbers: 220788, 230952 & 233742TB-1590K-SLot Numbers: 218700, 221465 & 223009ARTG Number: 99821
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd