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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01534-1
Product Name/Description	DePuy Synthes Confidence Kit Spinal Cement System Product Number: 283910000 Confidence Plus Kit Spinal Cement System, 11cc Lot Numbers: 133824, 145665, 145664, 135476, 152906 Confidence Kit Spinal Cement System Lot Numbers: 133831, 145669, 152908, 153883, 154956, 154957 ARTG Number: 211565
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/12/2017
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	(JJM) is initiating a recall of DePuy Synthes Confidence Kit Spinal Cement System has received reports where the Confidence cement products were difficult to visualise on X-ray, or could not be visualised on X-ray. It was identified that the Confidence Cement Kit lots impacted by this field action may contain Confidence cement products with incorrect amounts of contrast medium. The contrast medium allows for visualisation of the cement under X-ray imaging.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson is advising users to inspect stock and quarantine any remaining units of the affected product for return. This action has been closed out on the 21/11/2018.
Contact Information	1300 562 711 - JJM Customer Service