Events

Retiro De Equipo (Recall) de Twinfix Quick-T Knot Pusher Suture Cutters

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-00938-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-14
  • 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-00938-1
  • 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
    Smith & nephew have identified a packaging issue through internal testing. the twinfix quick-t knot pusher suture cutter could be subject to breaches of its sterile packaging. in the event the device is presented for use and a breach in the sterile barrier is not noticed, a non-sterile device could enter the surgical field. smith & nephew has received no customer complaints indicating a packaging breach or a post-operative infection.
  • Acción
    Smith & Nephew is advising users to discontinue use of affected products and quarantine the device(s). The devices are to be returned to Smith & Nephew.

Device

Twinfix Quick-T Knot Pusher Suture Cutters
  • Modelo / Serial
    Twinfix Quick-T Knot Pusher Suture CuttersProduct Number: 7209417Batch Numbers: 50412843, 50477278, 50527184ARTG Number: 112714
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd