Events

Rappel de Integra Mayfield Ultra 360 Base Unit

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-2015-RN-00052-1
  • Classe de risque de l'événement
    Class I
  • 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-2015-RN-00052-1
  • 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
    Mayfield ultra 360 base units may experience a failure of the locking system during use due to the excessive clearance between the inner diameter (bore) of the cam rod and the mating post that may potentially result in adverse patient health consequence in the event a breakage occurs during neurosurgical use.No complaint reports have been received in australia or new zealand.
  • Action
    Customers are to be alerted to this issue and are advised to discontinue use of the device until lntegra verifies their device does not have excessive clearance or if it does, the excessive clearance is corrected. This action has been closed-out on 19/08/2016.

Device

Integra Mayfield Ultra 360 Base Unit

Manufacturer

Integra Neurosciences Pty Ltd