Events

Rappel de MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.)

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-2014-RN-01367-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-16
  • 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-2014-RN-01367-1
  • 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 become aware that there is a higher occurrence rate of implant damaged during intra-operative handling for the part number noted above. additionally, a loss of adhesion between the barrier sheet and the porous sheet may be also experienced during intra-operative handling and modification. post-operative harm is unlikely to be associated or identified with the use of the affected device.
  • Action
    Stryker is informing all the MEDPOR barrier users of the issue and recalling the device. A Stryker Representative will contact the customer to arrange for product return and replacement. This action has been closed-out on 18/07/2016.

Device

MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or re...
  • Modèle / numéro de série
    MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.)Catalogue Number: 9305Lot Numbers: A1312011, 77004 & 81799ARTG Number: 187178
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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