Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01129-1
Product Name/Description	CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels) Reference/Catalogue Number: CS-023 Affected Lots: 267221 to 695063 ARTG Number: 94017
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	26/08/2016
Responsible Entity	ConMed Linvatec Australia Pty Ltd
Reason/Issue	The manufacturer has received complaints of damage to the electrode shaft insulation, which could increase the risk of a patient burn. To date, ConMed has not received any reports where this has led to illness or injury.
Recall Action	Recall
Recall Action Instructions	ConMed Linvatec is advising users to immediately discontinue use of the affected product and to return it to ConMed Linvatec for credit or replacement. This action has been closed-out on 10/05/2017.
Contact Information	1800 238 238 - ConMed Australia Customer Service