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MicroAire Surgical Instruments, LLC recalls SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Recalled August 14, 2019 · FDA recall Z-2222-2019 · MicroAire Surgical Instruments
Hazard
There was a higher than normal incidence rate of the blade not retracting when tightening. · FDA Class II
Units
103
Sold at
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.
Description
There was a higher than normal incidence rate of the blade not retracting when tightening.
Product
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Manufacturer(s)
MicroAire Surgical Instruments, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →