Recall Z-2107-2018 ยท HRX Arthroscope
MicroAire Surgical Instruments, LLC
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 tunne
| Date | May 25, 2018 (initiated Apr 19, 2018) |
| Status | Terminated |
| Reason | The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced. |
| 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 notification@microaire.com or via fax at 800-648-4309. If you have no quantity of IFUs remaining, there a |
| Quantity | 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, Se |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912871 | INSIDE JOB 3M Health Care, Ltd., Aug 9, 1991 |