Events

Rappel de Synream Medullary Reamer Head Size 13.5mm

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-01241-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-18
  • 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-01241-1
  • 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 part number and lot number is etched as dimension 13.5mm while the actual dimension is 14mm.If a 14mm reamer head is labelled and etched as a 13.5mm, there is the potential that the surgeon would be advancing 1.0mm versus 0.5mm; thus, there is a risk of the reamer head jamming. surgical delay could occur as the reamer head is removed from the medullary canal and bone debris is removed or the reamer head is replaced with another reamer head. there is also the potential for damage to the bone.
  • Action
    JJM is advising users to inspect stock and return any of the affected product to JJM for replacement with unaffected stock. This action has been closed-out on 24/08/2016.

Device

Synream Medullary Reamer Head Size 13.5mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes