| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00852-1 |
| Product Name/Description |
REX Rehab and REX P Devices (robotic walking device which is worn on the lower limbs by mobility-impaired users to provide enhanced functional mobility for exercise and rehabilitation purposes)
All devices affected
ARTG Numbers: 237572, 271519 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Rex Bionics has been made aware of a patient injury, relating to incorrectly securing the heel stops on the REX. The patient suffered bilateral upper and lower tibial and bilateral lower fibular fractures following a spasm which resulted in unsecured heel stops moving backwards. The injuries may have been exacerbated by the use of Ankle Foot Orthoses (AFO) which restricted the users’s Range of Motion greater than required by REX.
The heel stop must be correctly aligned with the measurement on the footplate corresponding to the User’s ankle to hind-foot measurement. Once adjusted, the heel stop must be secured by tightening the locking nut. Failure to do this may cause the User’s leg to move out of alignment, which may result in serious injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Rex Bionics is advising users of the importance of the correct heel stop adjustment, and securing using the tightening of the locking nut. Revised Instructions for Use (IFU) will be provided regarding the heel stops and the use of Ankle Foot Orthoses which limit the range of motion for a patient. This action has been closed out on 16 June 2017. |
| Contact Information |
03 9618 8216 - REX Bionics |