| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01030-1 |
| Product Name/Description |
Straight Adjustable Gastric Band
Product Code: 2200X & BD2XV
All lot numbers affected
ARTG Number: 94766 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Ethicon Endo-Surgery, has determined that the Straight Adjustable Gastric Band was unable to pass the internal test for 'Force to Close'. As a result surgeons may experience difficulty in locking the Straight Gastric Band buckle during implantation. Once the product is locked, the gastric band will remain in place and will function as intended. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is requesting customers to return affected product for a credit note. The Straight Adjustable Gastric Band will not be available in the market in the future. |
| Contact Information |
1800 252 194 - JJM Customer Service |