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