Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00112-1
Product Name/Description PlasmaSORD

Product Code: 962000PK

ARTG Number: 141561
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/02/2015
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue Based on a concern raised in the US relating to the potential risk of transcoelomic spread of undiagnosed cancerous tissue with the use of morcellators in the treatment of uterine fibroids, the manufacturer has issued an updated IFU which has been included in this communication.
Recall Action Recall for Product Correction
Recall Action Instructions Olympus 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:
- This action has been closed-out on 18/07/2016.
Contact Information 1300 132 992 - Olympus Australia Pty Ltd