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).
Recall
- Recall Number
- Z-2107-2018
- Event Number
- 80095
- Firm
- MicroAire Surgical Instruments, LLC
- FEI Number
- 2020601
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 19, 2018
- Posted
- May 25, 2018
- Terminated
- April 10, 2020
- Address
- 3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006
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).
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
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.
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.
2009