Events

Rappel de Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-2015-RN-00569-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-29
  • 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-2015-RN-00569-1
  • 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 affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification whichcould result in intraoperative breakage.In the event of an intraoperative breakage a surgical delay could occur. breakage of the instrument into fragments during active use could lead to a significant prolongation of surgery time as the surgeon attempts to retrieve the pieces including use radiographic imaging to determine location and size of fragment.
  • Action
    Johnson & Johnson Medical is requesting their customers to check their inventory to determine if they have any affected product. Affected stock must be quarantined in preparation for return to Johnson & Johnson Medical. This action has been closed-out on 05/12/2016.

Device

Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femu...
  • Modèle / numéro de série
    Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set)Part Number: 03.120.023Multiple lot numbers affectedARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes