SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
FDA Recall Z-2222-2019 · Posted None
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Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusTerminated
Product CodeHRX
Date Initiated2019-06-26
Date Terminated2020-04-29
Product Quantity103
Reason for Recall
There was a higher than normal incidence rate of the blade not retracting when tightening.
Firm 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 [email protected] 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 8:30 AM and 5:00 PM (EST) Monday through Friday.
Root Cause
Component change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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