Recall Z-0944-2018 ยท PHL Powered Exoskeleton
Argo Medical Technologies Ltd
ReWalk Personal 6.0. Catalog number: 50-20-0004.
| Date | Aug 14, 2017 |
| Status | Terminated |
| Reason | Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula. |
| Root cause | Other |
| Action | Customers were notified via letter on 08/14/2017. |
| Quantity | 127 |
| Distribution | US and foreign. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160987 | ReWalk(TM) Rewalk Robotics, Inc., Jul 22, 2016 |