Recall Z-2222-2019 ยท HRX Arthroscope
MicroAire Surgical Instruments, LLC
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
| Date | Jun 26, 2019 |
| Status | Terminated |
| Reason | There was a higher than normal incidence rate of the blade not retracting when tightening. |
| Root cause | Component change control |
| Action | Urgent Medical Device Recall notification letters were sent to customers on 6/26/19. Additional customers identified later sent letters on 7/17/19. Regardless of the above IFU information, to be on the safe side, MicroAire is performing this recall and asking that you please complete and send back page two of this letter to notification@microaire.com or via fax at 800-648-4309. We will rework the handpiece (by replacing the handpiece head) and return it to you. If you have any questions about this Recall, please contact MicroAire Customer Service at 1-800-722-0822 between the hours of |
| Quantity | 103 |
| Distribution | The products were distributed to the following US states: CA, CT, FL, GA, IA, IL, IN, MD, MI, MN, MS, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Australia, Czech Republic, France, Germany, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912871 | INSIDE JOB 3M Health Care, Ltd., Aug 9, 1991 |