Events

Rappel de Coated Implant_Delta Extend

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 DePuy France SA.

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
    22011
  • Date de mise en oeuvre de l'événement
    2017-09-21
  • 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
    The manufacturer has determined that lots produced in a specific machine were manufactured in a manner in which the post's diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) cannot be assembled.
  • Action
    Product to be returned to supplier

Device

Coated Implant_Delta Extend
  • Modèle / numéro de série
    Model: , Affected: Modular Centered Epiphysis Size 1 HA, Modular Eccentric Epiphysis Size 1 Left HA, Modular Eccentric Epiphysis Size 1 Right HA, Modular Centered Epiphysis Size 2 HA, Modular Eccentric Epiphysis Size 2 Left HA, Modular Eccentric Epiphysis Size 2 Right HA
  • Manufacturer
    DePuy France SA

Manufacturer

DePuy France SA