Events

Rappel de Synthes Cortex Screw

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Synthes GmbH.

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
    20109
  • Date de mise en oeuvre de l'événement
    2016-05-02
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Cause
    Specific part and lot of the 4.5mm cortex screws, length 20mm may contain a 4.5mm cortex screw that s 22mm in length. the screws are both etched and labelled with the 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., 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.
  • Action
    Product to be returned to supplier

Device

Synthes Cortex Screw
  • Modèle / numéro de série
    Model: 414.82, Affected: 2610310
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH