Events

Rappel de Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium

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-2016-RN-00570-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-03
  • 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-2016-RN-00570-1
  • 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 and lot numbers of the 4.5mm cortex screws, length 20mm, may contain a 4.5mm cortex screw that is 22mm in length; the screws are both etched and labelled with the affected 20mm part numbers.The outside package labelling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. if detected prior to insertion it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it.In addition, the potential harm of damage to surrounding structures including damage to articular surface during insertion could occur, depending upon the location and angle of screw. a screw that is too long can also result in soft tissue damage (soft tissue irritation) if not recognised during the procedure. at this time there have been no reports of patient involvement.
  • Action
    JJM is advising users to inspect stock and quarantine the affected units prior to their return to JJM. Past surgical results should be reviewed at the discretion of the surgeon for patients who have been implanted with screws from this particular lot number. This action has been closed out on 19/01/2017.

Device

Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes