Events

Rappel de Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Tornier 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-2014-RN-00973-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-20
  • 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-2014-RN-00973-1
  • 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
    Tornier sas has identified that some reversed cut guides have been incorrectly assembled during the manufacturing process. a faulty guide will generate an incorrect version measurement and may cause confusion or an improper humeral head resection. all the parts affected come from the same lot number (dp0213287).
  • Action
    Tornier Pty Ltd have all the affected products within their warehouses or their distributors warehouses. Tornier is checking the stock or requesting the distributors to check the stock and if faulty guides are identified, will replace the faulty guides with new ones. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)
  • Modèle / numéro de série
    Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)Item Number: MWF011Lot Number: DP0213287ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd