Device recall
Z-1975-2025: Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx…
FDA device recall · Class II · MicroAire Surgical Instruments, LLC
Key facts
| Recall number (Z-number) | Z-1975-2025 |
|---|---|
| Recall event | 96868 |
| Product | Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack… |
| Product code | EMF |
| Recalling firm | MicroAire Surgical Instruments, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K223406 |
| FEI number | 2020601 |
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