Events

Rappel de VDR Proximal Targeting Guide in Acu-Loc 2 Loan sets

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical & Optical Instruments Australia 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-00162-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-19
  • 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-00162-1
  • 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
    There is a chance that the vdr proximal targeting guide will crack and/or break after repeated use in surgery. if the instrument breaks, it may result in pieces not being removed from the patient and therefore causing prolonged surgery, soft tissue damage, histological and/or allergic reaction.
  • Action
    Medical and Optical are advising users that all affected devices are being replaced with "black" guides unaffected by this issue.

Device

VDR Proximal Targeting Guide in Acu-Loc 2 Loan sets
  • Modèle / numéro de série
    VDR Proximal Targeting Guide in Acu-Loc 2 Loan setsPart Numbers: 80-0700 (yellow), 80-0702 (yellow), 80-0704 (yellow), 80-0701 (yellow), 80-0703 (yellow), 80-0705 (yellow)Manufactured prior to 28 August 2012ARTG Number: 97308
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd