Events

Rappel de Stryker Shape Arm Kit Left

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 Communications 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
    16450
  • Date de mise en oeuvre de l'événement
    2014-03-25
  • 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 that there is a remote likelihood of the lock washer and screw that secures the monitor onto the shape arm not to be present. if not present the monitor could separate and dislodge from the arm potentially resulting in injury., the shape arm is an articulating arm for the boom system. it is intended for the mounting/ positioning of a flat panel monitor that is used to view/ perform surgery. the monitor is attached to the shape arm by standard vesa/ tilter bracket that is installed onto the shape arm and is secured with a lock washer and screw., the shape arm does not sustain or support life.
  • Action
    Product to be modified

Device

Stryker Shape Arm Kit Left

Manufacturer

Stryker Communications Inc
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    NZMMDSA