Events

Rappel de Integra Duragen Graft Matrix

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Integra LifeSciences Corporation.

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
    14534
  • Date de mise en oeuvre de l'événement
    2013-04-19
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Integra Neurosciences Pty Ltd (NZ), 5B Suite B, 331 Rosedale Road, Albany, Auckland 0632
  • Cause
    Specific lots of some collagen products may have deviated from a production process. the affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. higher endotoxin levels may result in fever in the immediate postoperative period. the manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots., the health hazard evaluation (hhe) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods december 2010 to may 2011, and then december 2012 to february 2013, may possibly be affected.
  • Action
    Product to be returned to supplier

Device

Integra Duragen Graft Matrix
  • Modèle / numéro de série
    Model: ID-1101(1), 1D-1105-(1), 1D-1301-(1), 1D-1305-(1), 1D-2201-(1), 1D-2205-1, 1D-3301(1), Affected:
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation