Events

Rappel de Cemented resurfacing patellar implant, Ø 33mm and 36mm

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-01013-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-15
  • 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-01013-1
  • 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
    It has been reported to amplitude that sealing of some pouches is not as resistant as intended and could compromise their integrity, resulting in non-sterile devices. this may increase the risk of post-operative infection and may lead to an increased surgical time to locate an alternative device.
  • Action
    Amplitude is advising users to inspect stock and quarantine the affected batches for return. This action has been closed-out on 10/05/2017.

Device

Cemented resurfacing patellar implant, Ø 33mm and 36mm
  • Modèle / numéro de série
    Cemented resurfacing patellar implant, Ø 33mm and 36mmCemented resurfacing patellar implant - Ø 33mmReference Number: 1-0200833Batch Number: 236419Cemented resurfacing patellar implant - Ø 36mmReference Number: 1-0200836Batch Number: 236412ARTG Number: 216375
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd