| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00938-1 |
| Product Name/Description |
Twinfix Quick-T Knot Pusher Suture Cutters
Product Number: 7209417
Batch Numbers: 50412843, 50477278, 50527184
ARTG Number: 112714 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew have identified a packaging issue through internal testing. The Twinfix Quick-T Knot Pusher Suture Cutter could be subject to breaches of its sterile packaging. In the event the device is presented for use and a breach in the sterile barrier is not noticed, a non-sterile device could enter the surgical field. Smith & Nephew has received no customer complaints indicating a packaging breach or a post-operative infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smith & Nephew is advising users to discontinue use of affected products and quarantine the device(s). The devices are to be returned to Smith & Nephew.
This action has been closed-out on 20/03/2018. |
| Contact Information |
02 9857 3908 - Smith & Nephew |