Events

Rappel de Stryker Triathlon Tibial Alignment Ankle Clamp EM

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
    17924
  • Date de mise en oeuvre de l'événement
    2015-02-27
  • 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
    Stryker orthopaedics carried out a recall for product correction in july 2013 due to complaints associated with cracks or fracture of the plastic triathlon tibial alignment ankle clamp (old design). this issue may lead to potential complications during surgery in the event a replacement sterile ankle clamp is required mid-procedure, which may create a delay exceeding 30 minutes in duration. stryker will organise the swap out of any old plastic clamps for the new metal clamps.
  • Action
    Product to be exchanged

Device

Stryker Triathlon Tibial Alignment Ankle Clamp EM
  • Modèle / numéro de série
    Model: Catalogue Number: 65412609. Affected Kits: 65418002-T, 65418030-T, TRIAR36PREP-T, WKSHP65418002-T & SHAPECONV-T, Affected: Lot Numbers: Lots prior to X9L06
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

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