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Vari-Flex Junior Foot Prosthesis

Published: June 9, 2022Recall ID: fc355d0a-6a20-4c88-870b-9cbf39785896Category: generalCountry: Australia

Reason for Recall / 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).

Product Description & Identification

Reason / 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). Hazards: If the prosthetic breaks, the user may fall, increasing the risk of injury. What to 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.

Affected Products

Vari-Flex Junior Item Number: VJB0xyyz ARTG 308050 (Ossur Australia Pty Ltd - Dynamic-response foot prosthesis)

Additional Source Details

FieldValue
Guid › #textfc355d0a-6a20-4c88-870b-9cbf39785896
Guid › @ is Perma Linkfalse
Linkhttps://www.productsafety.gov.au/search-consumer-product-recalls/vari-flex-junior-foot-prosthesis
Pub DateThu, 09 Jun 2022 00:00:00 +0000
Extracted imagehttps://www.productsafety.gov.au/system/files/styles/large/private/Vari-Flex%20Junior%20Foot%20Prosthesis.jpg?itok=7tZdIux9

Overview

  • Risk LevelMobility and accessibility aids
  • DistributionAustralia
Official Agency Alert