FDA Devices Moderate Class II Terminated

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

Reported: August 14, 2019 Initiated: June 26, 2019 #Z-2222-2019

Product Description

Reason for Recall

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

Details

Recalling Firm: MicroAire Surgical Instruments, LLC
Units Affected: 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.
Location: Charlottesville, VA

Frequently Asked Questions

What product was recalled? ▼

SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014. Recalled by MicroAire Surgical Instruments, LLC. Units affected: 103.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2222-2019.