| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00406-1 |
| Product Name/Description |
ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
Product No: 72201537
All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019
ARTG Number: 112714 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew internal investigation found the packaging material and design to be insufficient to prevent the ULTRA FAST-FIX Knot Pusher Suture Cutter’s sharp edges from potentially puncturing the pouch and rendering the device unsterile. To date there have been no complaints or adverse effects associated with this issue.
This could potentially lead to a post-operative infection.
To date there have been no complaints or adverse effects associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smith & Nephew is advising their customers to inspect the inventory and quarantine the affected devices immediately. A Smith & Nephew customer service representative will contact the customer to arrange collection of any affected products and advise on substitute devices available. This action has been closed-out on 11/08/2016. |
| Contact Information |
02 9857 3999 - Smith & Nephew Surgical Pty Ltd |