Events

Rappel de SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker 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-2015-RN-00574-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-29
  • 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-00574-1
  • 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
    Stryker has been made aware of a spike in the occurrence of tip breaks identified for the 90r probe. the investigation triggered by same confirmed the shape and location of the tip break in each case to be the same. in each event a small piece from the distal end of the alumina ceramic broke off. the geometry of this type of crack differs from those normally observed by serfas probes.
  • Action
    Customers are asked to check any SERFAS 90° Energy Probe items in their possession and quarantine any affected units immediately . A Stryker Representative will coordinate an inspection of your affected items in quarantine. Any affected items will be removed by the Stryker Representative and a credit will be issued. This action has been closed-out on 08/08/2016.

Device

SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)
  • Modèle / numéro de série
    SERFAS 90° Energy Probe (90R Probe) (Electrosurgical system electrode)Item Number: 279-350-101Affected Lots: 13128AE2 to 14337AE2ARTG Number: 146512
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA