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