FDA Device recall Z-2107-2018
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev by Microaire Surgical Instruments, citing the Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2107-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-19 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Microaire Surgical Instruments |
| Distribution | US |
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 (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
Reason
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Identifiers
| code_info | All products distributed from 1/1/13 to 2/23/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2107-2018%22
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