Events

Safety Alert for Confidence Spinal Cement System

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

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
    2013-01-22
  • Event Date Posted
    2013-01-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130122b.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: depuy confidence spinal cement system medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning all lots of confidence spinal cement system 5cc kit, confidence spinal cement system 7cc kit, confidence spinal cement system 11cc plus kit and confidence spinal cement system kit(catalogue numbers 283905000, 283907000, 283910000 and 283913000). the cement mixer used to prepare cement for surgery has been identified to not turn properly. the event may be described as the mixer being "jammed" or "stuck" and not able to turn which could result in surgical delay in order to prepare another kit or the inability to complete the procedure if an additional kit is not available thereby exposing the patient to additional anesthesia in another surgical procedure. according to the local supplier, the affected products were distributed in hong kong and have been located and returned. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 january 2013.

Device

Confidence Spinal Cement System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DePuy Confidence Spinal Cement System
  • Manufacturer
    DePuy

Manufacturer

DePuy