Recall Z-2222-2019— MicroAire Surgical Instruments, LLC

Name: FDA recall Z-2222-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-26

Class II · Terminated

Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2019-06-26, terminated 2020-04-29. It names one FDA 510(k) clearance: K912871. Product: SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014. Reason: There was a higher than normal incidence rate of the blade not retracting when tightening..

Recalling firm: MicroAire Surgical Instruments, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-06-26
Terminated: 2020-04-29
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K912871 — INSIDE JOB3M Health Care, Ltd.·cleared 1991-08-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.