Events

Rappel de VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432

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-01262-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-24
  • 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-01262-1
  • 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
    During a product presentation it has been recognised that a screw is not held by the screwdriver blade. the missing retaining function is caused by the inner torx of the screws partly being out of specification. investigations have revealed that screws might exceed given tolerances. a missing retaining function can lead to the surgeon having difficulties to pick the screw out of the screw rack without any further means, such as tissue forceps or other forceps, or during transfer of the screws. difficulties during pick up or transfer of the screws could potentially cause additional time under anaesthesia due to prolongation of surgery.
  • Action
    Stryker is advising users that the affected screws can be continued to be used and will be replaced once unaffected stock is available. This action ha been closed-out on 29/08/2016.

Device

VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432
  • Modèle / numéro de série
    VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432Multiple Lot Numbers affectedIncluded in VariAx Compression EPS system trayCatalogue Number: 940081-TAll lot numbers affectedARTG Number: 239272
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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