Events

Rappel de ACHILLON Minimally Invasive Achilles Tendon Suture System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00825-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00825-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    ACHILLON Minimally Invasive Achilles Tendon Suture SystemCatalogue Number: 119700NDAll Lot Numbers affectedARTG Number: 173933
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd