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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00701-1
Product Name/Description Sinus-SuperFlex-635 Self-expanding Nitinol Stent System

Model numbers: 8606-6200 and 8607-6200

Lot Numbers: Q009591, Q009592, Q008259, Q010150 and Q015955

ARTG Number: 178915
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 12/08/2015
Responsible Entity Pyramed Pty Ltd
Reason/Issue An investigation of field complaints indicates an increased number of deployment issues. Non-deployments were reported as well partial deployments of the stent. Partially deployed stents may require additional intervention by a doctor due to stent elongation or fracture.

This does not affect any patients with an implanted stent of this length since the problem may only occur during the implantation of the stent.
Recall Action Recall
Recall Action Instructions Customers are advised to remove all affected products from their inventory and quarantine them in a separate area for collection by Pyramed Pty Ltd. This action has been closed-out on 18/02/2016.
Contact Information 1800 651 882 - Pyramed Pty Ltd