MicroAire Surgical Instruments, LLC recalls SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

Recall date

June 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2222-2019

FDA classification

Class II

Brand / firm

MicroAire Surgical Instruments, LLC

Sold / distributed

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.

Why it was recalled

There was a higher than normal incidence rate of the blade not retracting when tightening.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014