Z-2107-2018Class II

MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece...

Name: Z-2107-2018 MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece...
Creator: MicroAire Surgical Instruments, LLC
Published: 2018-04-19
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2018-04-19 / Terminated / root cause: labeling and UDI

FDA source

MicroAire Surgical Instruments, LLC began a recall of MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release... on 2018-04-19. FDA classified it as Class II and gives the reason as "The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2107-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-19
Posted: 2018-05-25
Terminated: 2020-04-10
Recalling firm: MicroAire Surgical Instruments, LLC
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).
Product code: HRX Arthroscope
Reason for recall: The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Urgent Medical Device Recall letters were distributed to customers. The letters instructed customers to do the following: If you have some quantity of IFUs remaining, we're asking you to destroy your current copies, IM-SMARTRELEASE Rev. A-D, and replace them by going on-line at MicroAire at www.microaire.com/resources. Click Carpal Tunnel, then SmartRelease Instruction Manual to obtain the latest version, IM-SMARTRELEASE Rev. E. Please complete and send back page two of this letter to [email protected] or via fax at 800-648-4309. If you have no quantity of IFUs remaining, there are no further activities needed by you except for the mandatory returning of page two of this letter to [email protected] or via fax at 800-648-4309. For further questions, please call (800) 722-0822.
Quantity in commerce: 2009
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of: Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.
Product codes and lots: All products distributed from 1/1/13 to 2/23/18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2107-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07

Product code HRX

K912871Class IIInside Job3M Health Care, Ltd. / cleared 1991-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)