Events

Rappel de Brainlab Disposable Reflective Marker Spheres (DRMS)

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 Northern Digital 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
    19094
  • Date de mise en oeuvre de l'événement
    2015-11-09
  • 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
    Some drms may separate at the mid-point where the two halves of the sphere are sealed together. separation may occur during installation of the spheres onto reference arrays or surgical tools (i.E., when threading them onto posts), or potentially after installation on tools that are impacted with high forces. should such a drms separate during a surgical procedure, there is a possibility for:, - a portion of the sphere, its reflective coating and cured or uncured adhesive contacting patient tissues., - contamination of surgical trays, surgical drapes, surgical tools or physicians' gloves due to contact with the separated component., - prolongation of surgery due to the need to replace the broken sphere., the resulting separated sphere halves will not continue to be tracked by the brainlab image guided surgery system.
  • Action
    Product to be returned to supplier

Device

Brainlab Disposable Reflective Marker Spheres (DRMS)
  • Modèle / numéro de série
    Model: 41773G, 41774G, 41772G, Affected: 1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301, C110411401
  • Manufacturer
    Northern Digital Inc

Manufacturer

Northern Digital Inc