Events

Rappel de Score Extension Stem for Total Knee Prosthesis - Cemented

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Amplitude 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-00706-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-10
  • 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-00706-1
  • 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
    Amplitude has become aware through transport simulation tests that the packaging pouches of some devices could be damaged. the pouches function as the sterile barrier of the device packaging. there is a risk of infection if a patient is implanted with a non- sterile implant. the implantation of non-sterile device is unlikely. the routine tests conducted on devices did not show any case of non-sterility and no clinical incident was reported in relation with loss of sterility of the device.
  • Action
    Amplitude is advising users to inspect stock and quarantine any remaining units of the affected products for return. Patients with implanted devices should be followed up as per standard hospital procedures.

Device

Score Extension Stem for Total Knee Prosthesis - Cemented
  • Modèle / numéro de série
    Score Extension Stem for Total Knee Prosthesis - CementedMultiple product codes affectedAll lot numbers affectedARTG number: 242001
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd