Events

Rappel de Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative and Pangea Degenerative Systems, Pedicle Awl 4.0mm with Canevasit and Silicone Handle (internal fixation system)

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-00977-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-09
  • 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-00977-1
  • 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 surgical technique guides and product labelling for the affected systems currently describe the pedicle awls as 4.0mm for use with screws (4.0mm – 7.0mm). these awls should be used with 5.0mm – 7.0mm screws. in the event that a ø4mm awl is used for a ø4mm screw, there is a risk that perforation of the cortex will be too wide and may result in screw pull-out or loosening. in the event that the cortex is perforated wider than needed for insertion of a ø4mm screw, the failure would not typically be recognised. cases may occur, however, where a surgeon’s perception of torque to insert the screw does not have the desired level of fixation. in this case, the issue may be recognised. there have not been any reports of patient injuries as a result of the current labelling, and there have been no changes to the design or manufacture of the pedicle awls.
  • Action
    Johnson & Johnson Medical are providing a web link for users to obtain copies of the revised technique guides and labelling. This action has been closed-out on 29/08/2016.

Device

Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative and Pangea Degenerative Systems, ...
  • Modèle / numéro de série
    Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative and Pangea Degenerative Systems, Pedicle Awl 4.0mm with Canevasit and Silicone Handle (internal fixation system)Multiple Technique Guides AffectedLabelling:Pedicle Awl 4.0mm with Canevasit HandleProduct Code: 388.550Pedicle Awl 4.0mm with Silicone HandleProduct Code: 388.656ARTG Number: 155807
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes