Events

Rappel de DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences 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-2013-RN-00352-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-04-22
  • 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-2013-RN-00352-1
  • 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
    The production process may have deviated during the manufacture of specific lots.The product lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products.
  • Action
    Integra is recalling the affected product and is asking clinicans to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol.

Device

DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Rege...
  • Modèle / numéro de série
    DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix & DuraGen Suturable Dural Regeneration Matrix (Dura mater grafts indicated for the repair or primary closure of dura (brain and spinal chord) for regeneration)Catalogue Numbers: ID-1101-(I), ID-1105-(I), ID-1301-(I), ID-1305-(I), ID-2201-(I), ID-2205-I, ID-3305-(I), ID-4501-(I), DP-1013-I, DP-1022-I, DP-1033-I, DP-1045-I, DP-1057-I, DURS2291, DURS3391, DURS4591Multiple lots affectedARTG: 158829, 158825 & 158826
  • Classification du dispositif
    Neurological Devices
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd