Device recall
Z-1553-2021: ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits…
FDA device recall · Class II · Argo Medical Technologies Ltd
Key facts
| Recall number (Z-number) | Z-1553-2021 |
|---|---|
| Recall event | 87818 |
| Product | ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions. |
| Product code | PHL |
| Recalling firm | Argo Medical Technologies Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 10, 2021 |
| 510(k) numbers | K160987, K200032 |
| FEI number | 3007615665 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database