| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00107-1 |
| Product Name/Description |
Morce Power Plus 2307
ARTG Number: 169348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Following a regulatory review of the tissue morcellation system in general, the manufacturer has updated the contraindication guidelines section of the Instructions for Use (IFU) for this system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Endocorp Pty Ltd is notifying hospitals of the expanded contraindications, warnings and risk associated with the use of power morcellators.
The TGA has published information on the risks associated with power morcellators on the TGA website at:
- https://www.tga.gov.au/alert/laparoscopic-power-morcellators-29-april-2014
- https://www.tga.gov.au/alert/laparoscopic-power-morcellators-update-4-august-2014. This action has been closed-out on 02/06/2016. |
| Contact Information |
1800 816 003 - Endocorp Pty Ltd |