Events

Rappel de CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)

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-2014-RN-00306-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-03-13
  • 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-00306-1
  • 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
    Integra lifesciences has identified that some lots of 23 khz sterile torque wrenches contain wrenches that will only fit 36 khz cusa handpiece tips. the green colour code and size printed on the wrenches are correct for a 23 khz wrench, but the affected wrench size insert is smaller than it should be and will only fit a 36 khz cusa tip.
  • Action
    Integra is requesting end users to determine if they have any units from the affected lot. If the outer box has a green dot sticker the torque wrench can be used. If the box does not have a green dot sticker end users are requested to quarantine the unit. An Integra sales representative will arrange for the affected units to be inspected. In the event that an inspection cannot be undertaken in a reasonable time replacement units will be arranged.

Device

CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)
  • Modèle / numéro de série
    CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)Catalogue Number: C5601Lot Numbers: 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873, 1135014ARTG Number: 151 502
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd