Events

Rappel de DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm.

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-00723-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-07
  • 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-00723-1
  • 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 pty. ltd. (jjm) is issuing a recall for all lots of the depuy synthes socket, hexagonal ø 4.0mm/11.0mm. the socket is a cannulated instrument used to insert the end caps in the proximal femoral nail anti-rotation (pfna), pfna-ii, and the antegrade femoral nail (afn). there is a potential for the socket-hex tip to break into fragments during use if too much force is applied.As the affected item has been reported to break intra-operatively, there is potential for surgical delay while the fragments are retrieved. consequently, surgical delay may occur while a replacement instrument or alternative device is located to insert the end cap. in addition, an adverse tissue reaction may possibly occur if any stainless steel fragments from the socket are not retrieved from the patient.
  • Action
    JJM is requesting their customers to immediately check their inventory to determine if their facility has any affected product. If affected stock is identified quarantine prior to organising its return to JJM.

Device

DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm.

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes