| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00732-1 |
| Product Name/Description |
Vari-Flex Junior
Item Number: VJB0xyyz
ARTG 308050
(Ossur Australia Pty Ltd - Dynamic-response foot prosthesis) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/06/2022 |
| Responsible Entity |
|
| Reason/Issue |
Ossur has received customer complaints related to broken Vari-Flex Junior prosthetic feet, with failures occurring in situations where sudden high impact twisting or bending is applied to the foot. Such circumstances can happen in sports activities, including for example football / soccer. Failure is described as carbon foot breaks in the arch, midway between the heel bolts and the top of the adapter.
Ossur has not received any reports of injuries, however there is the potential the user may fall as a result of device breakage if used in high impact sports/activities. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised that to ensure compliance and user safety, the IFU has been updated to include additional warnings against high impact and added device selection information, as highlighted in the customer letter (supplied to impacted facilities by the sponsor).
Customers are requested to monitor and review the activities of patients already fitted with the Vari-Flex Junior, and ensure patients and/or their guardians are aware of this important update, and provide them a copy of the letter and updated instructions.
If customers have further distributed the product, they should notify the necessary persons at once of this Product Defect Correction.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 123 268 - Ossur Customer Service |