Events

Rappel de Teflon Tube T2 Humerus, Sterile

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-00438-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-25
  • 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-00438-1
  • 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 shelf life study, it was found that particular lots of product failed a dye penetration test demonstrating a deficient seam in the sterile packaging. the seams of the pouches made by one supplier were confirmed to be within specification and do not exhibit any non-conformance. the in-house made cross seam was confirmed to be manufactured out of specification. thus these lots have been deemed as having potentially insufficient packaging integrity and therefore regarded to be unsterile.
  • Action
    Stryker is notifying surgeons of the issue and provided advice on patient follow up. This action has been closed-out on 04/05/2017

Device

Teflon Tube T2 Humerus, Sterile
  • Modèle / numéro de série
    Teflon Tube T2 Humerus, SterileCatalogue Number: 18060073SLot Number: K0432D3ARTG Number: 139623
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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