Events

Safety Alert for Nubac Trial Inserter – 43-TRL-INSERTER

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Pioneer Surgical Technologies.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-05-03
  • Event Date Posted
    2012-05-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120503e.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: pioneer surgical nubac trial inserter – 43-trl-inserter it has come to our attention that medical device manufacturer, pioneer surgical technologies, has issued a field safety corrective action concerning nubac trial inserter – 43-trl-inserter. the manufacturer has identified that the affected device can wear causing it not to function as designed. this wear may cause the trial spacer to become detached from the inserter while in use. if this takes place, the trial spacer may be difficult to remove from the patient which may cause patient injury during this removal process. the manufacturer advised that the device should be inspected prior to every use and they have developed a test fixture to be used to assist in the determination of the wear of the device. if you are in possession of the affected product, please contact your supplier for necessary actions. posted 03 may 2012.

Device

Nubac Trial Inserter – 43-TRL-INSERTER
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Pioneer Surgical Nubac Trial Inserter – 43-TRL-INSERTER
  • Manufacturer
    Pioneer Surgical Technologies

Manufacturer

Pioneer Surgical Technologies