Events

Rappel de Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(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 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-2017-RN-00304-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-02
  • 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-2017-RN-00304-1
  • 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
    Johnson & johnson medical have received a complaint that the location slot for the screw holding sleeve was machined 3 mm out of position. the presence of a screwdriver, (part number 314.560) which is not manufactured to specification, may result in a surgical delay due to the non-conformance. the combination of the non-conforming screwdriver and a retaining sleeve will result in a situation where the surgeon will have minor difficulty interfacing the screw with the driver and sleeve, but the surgeon should still be able to insert the screw. it is important to note that the surgeon may opt to utilise the screwdriver without the retaining sleeve. the resulting surgical delay is not anticipated to be clinically significant (<15 minutes) and no additional intervention is anticipated.
  • Action
    Customers are advised to quarantine and return the affected stock in their possession to JJM.

Device

Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as...
  • Modèle / numéro de série
    Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as part of the fixation system implantation kit)Part Number: 314.560Lot Number: 7722501ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes