Ossur Australia Pty Ltd — Vari-Flex Junior Foot Prosthesis

PRA number


Published date

Product description

Vari-Flex Junior

Item Number: VJB0xyyz

ARTG 308050
(Ossur Australia Pty Ltd - Dynamic-response foot prosthesis)

Photograph of Vari-Flex Junior Foot Prosthesis

Reasons the product is recalled

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). 

The hazards to consumers

If the prosthetic breaks, the user may fall, increasing the risk of injury. 

What consumers should 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.

Where the product was sold

New South Wales
South Australia
Western Australia

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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