Events

Retiro De Equipo (Recall) de ACHILLON Minimally Invasive Achilles Tendon Suture System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences 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-00825-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-20
  • 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-00825-1
  • 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
    Internal investigation by the manufacturer has identified that there is the possibility that one section of the outer package tyvek seal for the achillon suture system may not remain completely sealed if not used within its shelf-life of 5 years. the section of the seal affected is adjacent to the finger-lift used to open the outer blister and were it to occur the sterility assurance of the exterior surface of the inner package may be compromised. to date, no instances have been reported.
  • Acción
    Customers are requested to review their inventory and stop using the affected products immediately. Integra Neurosciences will advise customers on how to return the affected stock and provide credit or replacement products. This action has been closed-out on 10/05/2017.

Device

ACHILLON Minimally Invasive Achilles Tendon Suture System
  • Modelo / Serial
    ACHILLON Minimally Invasive Achilles Tendon Suture SystemCatalogue Number: 119700NDAll Lot Numbers affectedARTG Number: 173933
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd