Events

Rappel de Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument supplied as part of the fixation system implantation kit)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Synthes 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-2013-RN-00631-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-25
  • 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-00631-1
  • 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
    Synthes australia has received complaints in relation to breakages experienced with the reduction insert and pieces during spine surgery utilising the reduction instrument for spondylolisthesis, standard, for matrix 5.5.Once the reduction insert breaks, the instrument does not function as required.
  • Action
    Synthes are requesting their customers to immediately identify and quarantine any affected units. Local sales representatives will assist in the recovery of affected devices.

Device

Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument...
  • Modèle / numéro de série
    Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument supplied as part of the fixation system implantation kit)Part Number: 03.632.008 All lot numbers affectedARTG Number: 155807
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd