Events

Rappel de Duracon Augments - Tibial Wedge Implants

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-00971-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-02
  • 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-00971-1
  • 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 received two customer complaints regarding duracon tibial wedge implants that had punctured the packaging’s tyvek lid. in each case, the punctured tyvek lid was identified in the operating room and a new device was opened and used.In all stryker instructions for use (ifu) for the above referenced product, the end user is instructed to inspect the package for damage and, if present, to discard the device. operating room staff should conduct this packaging inspection for any breach in the outer and inner packaging. performing this inspection should mitigate this potential hazard. in the unlikely event the packaging is not inspected, there is a potential that a non-sterile implant will be implanted which may result in a post-operative infection.
  • Action
    All affected products in the market have been recorded as being used. Stryker has decided that the implanting and treating physicians should be made aware of this issue to facilitate review of their patients for this issue as part of the normal post-operative course of treatment. Stryker recognises that the implanting and treating physicians are in the best position to exercise the necessary medical judgment for their patients . This action has been closed-out on 05/12/2016.

Device

Duracon Augments - Tibial Wedge Implants
  • Modèle / numéro de série
    Duracon Augments - Tibial Wedge ImplantsCatalogue Numbers:6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405, 6630-6-410, 6630-6-425, 6630-6-430, 6630-6-450, 6630-6-455, 6630-6-470, 6630-6-475.Affected Lots: MultipleARTG Number: 242298
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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