Events

Rappel de Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand piece

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-00964-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-20
  • 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-00964-1
  • 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
    The adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the electric pen drive (epd) system to operate the colibri and colibri ii with the epd consoles. the adaptor can be inserted into the colibri or colibri ii handpiece and removed like a battery pack.There is a potential for the adapter for colibri and adapter for colibri ii to generate excessive internal pressure that may cause the respective products to burst. preliminary tests for this failure mode by the manufacturer have determined this scenario is highly unlikely to occur. there have been no injuries as a result of this issue.
  • Action
    JJM is advising users to inspect stock and quarantine any units of the affected adapters. The Colibri Drill system is able to be operated by the use of specific batteries; listed below. These products will be made available. • Universal battery charger, Product 05.001.204 • Battery case, Product 532.132 • 14.4V Lithium-Ion battery Product 532.103 • Sterile transfer product 532.104

Device

Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand piece
  • Modèle / numéro de série
    Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand pieceAdapter for Colibri, Electric Pen DriveProduct Number: 05.001.024Light Adapter for Colibri and Colibri II hand pieceProduct Number: 05.001.108All lots affectedARTG Number: 157072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes