OECDReference EN/AU/PS1101149
Vari-Flex Junior Foot Prosthesis
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- Vari-Flex Junior Foot Prosthesis
Official information
Risk and measures
- Risk or hazard
- 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). If the prosthetic breaks, the user may fall, increasing the risk of injury.
- Recommendations
- 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.
Official information
Economic operators
- Manufacturer
- Ossur Australia Pty Ltd
Territory
Geography
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
NagameAlert distinguishes content published by the source from its organisation and normalisation. Values marked “NagameAlert” belong to that processing layer. Always check measures, scope and updates in the official publication.