| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00825-1 |
| Product Name/Description |
ACHILLON Minimally Invasive Achilles Tendon Suture System
Catalogue Number: 119700ND
All Lot Numbers affected
ARTG Number: 173933 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigation by the manufacturer has identified that there is the possibility that one section of the outer package Tyvek seal for the Achillon Suture System may not remain completely sealed if not used within its shelf-life of 5 years. The section of the seal affected is adjacent to the finger-lift used to open the outer blister and were it to occur the sterility assurance of the exterior surface of the inner package may be compromised. To date, no instances have been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are requested to review their inventory and stop using the affected products immediately. Integra Neurosciences will advise customers on how to return the affected stock and provide credit or replacement products. This action has been closed-out on 10/05/2017. |
| Contact Information |
1300 550 599 - Integra Customer Service |