Events

Rappel de Wright Medical Claw and Claw II plates

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 Wright Medical Technology Inc.

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
    17259
  • Date de mise en oeuvre de l'événement
    2014-09-11
  • 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: Surgical Specialities (NZ) Limited, 4B Ride Way, Albany, AUCKLAND 0632
  • Cause
    It has been identified that the stainless steel used in claw and claw ii plates from the affected lots did not meet the manufacturing requirements, resulting in reduced strength and increased risk of warping under stress. if this occurs, the device could fail., if this problem occurred during surgery, it would be corrected immediately. however, surgery time would be increased., if an affected device has been implanted and did not fail during surgery, there is a remote possibility that it could fail before fusion of the bones occurs. if this happens, revision surgery will be required.
  • Action
    Product to be returned to supplier

Device

Wright Medical Claw and Claw II plates

Manufacturer

Wright Medical Technology Inc