FDA-Device2019-08-14Class II
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
MicroAire Surgical Instruments, LLC
Hazard
There was a higher than normal incidence rate of the blade not retracting when tightening.
Sold states
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.
Affected count
103
Manufactured in
3590 Grand Forks Blvd, N/A, Charlottesville, VA, United States
Products
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2222-2019Don't want to check this manually?
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