Events

Recall of NIO- INTRAOSSEOUS DEVICE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WAISMED LTD..

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
    91091
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-18
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    On july 29 2016 during the operation of the nio-a the needle was not released from the device as expected. the device was placed on the floor and after several minutes the needle was released spontaneously.

Device

NIO- INTRAOSSEOUS DEVICE
  • Model / Serial
    Model Catalog: NIO-A (Lot serial: Lot #: 1630023)
  • Product Description
    NIO-A
  • Manufacturer
    WAISMED LTD.

Manufacturer

WAISMED LTD.
  • Manufacturer Address
    ROSH HA'AYIN
  • Manufacturer Parent Company (2017)
    Waismed Ltd
  • Source
    HC