| TGA Action ID |
RC-2026-RN-00218-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Movita Ergonomix, Movita Round and Movita Sizer Breast Implants
Movita Ergonomix
Multiple material codes and batches
Movita Round
Multiple material codes and batches
Movita Sizer
Multiple material codes and batches |
| ARTG Number |
280546, 282778, 510445 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
LifeHealthcare were advised, after receiving a cleared shipment, that the container the shipment was in received fumigation with Sulfuryl Fluoride. The fumigation was conducted due to the presence of a product in the container that triggered an import requirement for fumigation.
LifeHealthcare are unable to guarantee whether the devices have been exposed to the fumigant, and if there is any residue in the product.
Update 30/04/2026:
LifeHealthcare have been advised that devices were not loaded into the container until after the fumigation had been performed and the container was fully cleared of the fumigant. The devices were not exposed to sulfuryl fluoride at any stage during transport.
There has been no exposure of the devices or their packaging to the fumigation agents. There is no clinical risk to patients. |
| Instructions for Customers/Users |
Customers are to:
- quarantine the affected stock
- return affected stock to LifeHealthcare
Update 30/04/2026:
There is no clinical risk to patients.
Implanted Devices:
- Patients can continue to be managed in line with standard clinical practice and routine follow up protocols.
Devices with Customers:
- Remaining inventory can continue to be utilised and does not need to be quarantined or returned.
Devices returned to LifeHealthcare
- No additional actions are required in relation to devices previously returned to LifeHealthcare. |
| Action Commencement Date |
25/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 060 168 - Life Healthcare |