Device recall
Z-2107-2018: MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release…
FDA device recall · Class II · MicroAire Surgical Instruments, LLC
Key facts
| Recall number (Z-number) | Z-2107-2018 |
|---|---|
| Recall event | 80095 |
| Product | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology… |
| Product code | HRX |
| Recalling firm | MicroAire Surgical Instruments, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2020 |
| 510(k) numbers | K912871 |
| FEI number | 2020601 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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