| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00405-1 |
| Product Name/Description |
LiquiBand FIX8 Hernia Mesh Adhesive Fixation Device
Product Code: FX001
ARTG Number: 233374 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Advanced Medical Solutions (AMS) extended claims in the instructions for use of LiquiBand FIX8 in May 2015 from "laparoscopic surgical repair of inguinal hernia, achieved through the fixation of polypropylene or polypropylene / polyester combination hernia mesh to the abdominal wall" to "laparoscopic repair of abdominal hernias, achieved through the fixation of prosthetic mesh to the abdominal wall and the approximation of peritoneum". A recent technical file audit by the Notified Body BSi has revealed that more data was required to support these extended claims. Until further notice, the FIX8 device should only be used as per the original instructions for use, version DRM 06 0528 01 (revision 1). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
AMS is providing users with revision 1 of the IFU that is to be used with stock that has been purchased and is currently in stock. Future shipments of the device will be shipped with IFU revision 1 until further notice.
This action has been closed-out on 21/03/2018. |
| Contact Information |
02 8114 1553 - LifeHealthcare |