PRA number
Published date
Product description
Vari-Flex Junior
Item Number: VJB0xyyz
ARTG 308050
(Ossur Australia Pty Ltd - Dynamic-response foot prosthesis)
What are the defects?
The Vari-Flex Junior foot prosthetic may break when sudden high impact twisting or bending is applied to the foot. This may occur during high impact sports or activities (soccer/football).
What are the hazards?
If the prosthetic breaks, the user may fall, increasing the risk of injury.
What should consumers do?
Customers will be contacted in writing and provided with an updated instruction for use sheet. The update will include additional warnings about high impact use and added information about selecting the device.
For more details, see https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00732-1
For further information, contact Ossur Customer Service on 1300 123 268.
Supplier
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.