Device recall
Z-2898-2011: AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that…
FDA device recall · Class II · Axiobionics, LLC
Key facts
| Recall number (Z-number) | Z-2898-2011 |
|---|---|
| Recall event | 59046 |
| Product | AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation. |
| Product code | GXY |
| Recalling firm | Axiobionics, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 29, 2013 |
| 510(k) numbers | K944543 |
| FEI number | 3008525454 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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