MicroAire Surgical Instruments, LLC: Medical Device Recall in 2018 - (Recall #: Z-2107-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: April 19, 2018

Date Posted: June 13, 2018

Recall Number: Z-2107-2018

Event ID: 80095

Reason for Recall:

The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.

Status: Terminated

Product Quantity: 2009

Code Information:

All products distributed from 1/1/13 to 2/23/18

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated