Events

Safety Alert for Side Fire Needles, part of 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
    2012-05-16
  • Event Date Posted
    2012-05-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120516.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 side fire needles, part of confidence spinal cement system™ medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning side fire needles, part of confidence spinal cement system™. during post market surveillance review of the confidence system, the manufacturer has found that the complaint rate for breakage of the side fire needles was higher than the anticipated occurrence rate in the design failure mode and effect analysis. upon evaluation of risk it was determined to reduce the level of risk, a communication would be sent out to all users of the products to reinforce proper technique and instructions for use. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 may 2012.

Device

Side Fire Needles, part of Confidence Spinal Cement System™
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DePuy Side Fire Needles, part of Confidence Spinal Cement System™
  • Manufacturer
    DePuy

Manufacturer

DePuy