Events

Field Safety Notices about NDI Disposable Reflective Marker Spheres

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by NDI Europe GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-07-10
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Ndi found that the marking beads in these production batches have the risk that the semicircles in the middle, along the adhesive surfaces, may be halved. .

Device

NDI Disposable Reflective Marker Spheres
  • Model / Serial
    41773 Disposable Reflective Marker Spheres (90 pcs) 41774 Disposable Reflective Marker Spheres (270 pcs) 41813 Disposable Reflective Marker Spheres (60 pcs)
  • Manufacturer
    NDI Europe GmbH

Manufacturer

NDI Europe GmbH