Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00007-1
Product Name/Description	NAJA Spinal Ligament Systems for Spinal Stabilisation Reference Numbers: RCBNAJ55LU, RCBNAJ55RU Batch Numbers: 141527, 141724, 141896, 151605, 151940, 151939, 152079, 152319, 171823, 170696, 172044, 151604, 152080 ARTG Number: 273278 (Evolution Surgical Pty Ltd - Spinal internal fixation system, intervertebral body)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/01/2018
Responsible Entity	Evolution Surgical Pty Ltd
Reason/Issue	The manufacturer, Cousin Biotech, through post-market surveillance systems has identified three successive cases of breakage of the metal connector clamping system that occurred during surgery. For these three incidents, there were no serious clinical outcomes for patients except a slight increase in operating time to use another medical device.
Recall Action	Recall
Recall Action Instructions	1. The letter should be passed on to end-users, to all persons concerned in your company, or to any other organisation (healthcare centers) to which potentially affected products have been sent. 2. Check stock and quarantine all unused devices with the batch numbers identified. 3. Complete the supplied form and return it to the email address provided for the sponsor to arrange the collection of affected units. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	02 9428 1084 - Customer Service Centre