Events

Rappel de Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)

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-2014-RN-00646-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-17
  • 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-00646-1
  • 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 packaging for item 400.688s (cortex screw ø 1.3 mm, self-tapping, length 8 mm, sterile) was found to contain product 400.808s (cortex screw ø 1.5 mm, self-tapping, length 8 mm, sterile). the presence of a screw that is 1.5mm in diameter instead of 1.3mm (or 1.3mm vs 1.5mm) may cause surgical delay if the surgeon may specifically require a 1.3 or 1.5mm due to the patient's impacted anatomical structure.
  • Action
    Customers are requested to isolate Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm from the affected lot for return to DePuy Synthes.

Device

Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)
  • Modèle / numéro de série
    Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw)Part Number: 400.808 Lot Number: 2798707 ARTG Number: 157068
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd