Recall Z-2107-2018— MicroAire Surgical Instruments, LLC
Class II · Terminated
Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2018-04-19, terminated 2020-04-10. It names one FDA 510(k) clearance: K912871. 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..
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-19
- Terminated
- 2020-04-10
- Firm location
- Charlottesville, VA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Data sourced from openFDA. This site is unofficial and independent of the FDA.