Events

Recall of Brainlab Disposable Reflective Marker Spheres (DRMS)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Northern Digital Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    19094
  • Event Initiated Date
    2015-11-09
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Reason
    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)
  • Model / Serial
    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