4 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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).
FDA Recall
Terminated
·MicroAire Surgical Instruments, LLC·Product code HRX·April 19, 2018
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
FDA Recall
Terminated
·MicroAire Surgical Instruments, LLC·Product code HRX·June 26, 2019
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 OUS only);
FDA Recall
Open, Classified
·MicroAire Surgical Instruments, LLC·Product code EMF·May 7, 2025
Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
FDA Recall
Terminated
·MicroAire Surgical Instruments, LLC·Product code GET·March 11, 2016