Events

Rappel de Stryker Prosthesis knee femoral component

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 Stryker Howmedica Osteonics.

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
    13559
  • Date de mise en oeuvre de l'événement
    2012-10-04
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Cause
    Manufacturer has become aware of potential packaging issue associated with various products. initial inspections of some items (as listed) revealed what the manufacturer refers to as “creep”. this is when the sterile barrier surface area decreases. at this point, no units have been found to have a full breach of the seal., technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. all product to be returned to the manufacturer.
  • Action
    Product to be returned to supplier

Device

Stryker Prosthesis knee femoral component

Manufacturer

Stryker Howmedica Osteonics
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    NZMMDSA