Events

Rappel de BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Corin 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-01518-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-18
  • 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-01518-1
  • 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
    Data from sources external to corin suggest that ceramic fragments from fractured ceramic components may remain in the joint following revision surgery, which can lead to premature wear of revision components if such revision components are made of non-ceramic materials. as a result, the instruction within the ifu for corin’s biolox delta ceramic components have been updated in respect of recommended actions in the case of revisions.
  • Action
    The IFU is being revised to include the following information in the ‘Warnings & Precautions’ section: In the case of revision due to a fractured ceramic component, when keeping a well fixed stem, the modular head must be replaced with a Biolox Option modular head where available. If a Biolox Option modular head is not available, in addition to revising the modular head, the femoral stem must also be revised to provide a suitable taper to which a new ceramic femoral ball head can be attached. In the event of revision not due to fracture of a ceramic component, when keeping a well fixed stem, the modular head must be replaced with a metal modular head or a Biolox Option ceramic modular head only.

Device

BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner
  • Modèle / numéro de série
    BIOLOX delta ceramic componentsBiolox Delta Modular Head and Trinity Ceramic LinerAll Part Number / Lot Codes ARTG Numbers: 211371 and 210774
  • Manufacturer
    Corin Australia Pty Ltd

Manufacturer

Corin Australia Pty Ltd