Events

Rappel de Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures)

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-2016-RN-01114-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-22
  • 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-2016-RN-01114-1
  • 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
    For a small portion of the affected lot, the seal between the top and base rollstock material of the product packaging may not have been manufactured correctly resulting in a sterile barrier breach. due to this breach in sterility, there is a potential for a bone or soft tissue infection which may require medical or surgical intervention.
  • Action
    Stryker is advising users to inspect inventory for the affected lots and quarantine immediately. Affected stock can be returned to Stryker for replacement with unaffected product. This action has been closed-out on 10/05/2017.

Device

Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tis...
  • Modèle / numéro de série
    Stryker Instruments Heavy Duty Sagittal Blade 18x0.97x90mm (used to cut bone and bone related tissue in orthopaedic procedures)Item Number: 6118-097-090Lot Number: 16029017ARTG Number: 140542
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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