Product description
Vari-Flex Junior
Item Number: VJB0xyyz
ARTG 308050
(Ossur Australia Pty Ltd - Dynamic-response foot prosthesis)
See a list of details to help identify the product
Reason 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.
Details to help identify the product
Supplier running the recall
Where the product was sold
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2022/19496 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.