FDA recall Z-2222-2019

Product

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.

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.

Key facts

Status

Terminated

Initiation date

2019-06-26

Report date

2019-08-14

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Charlottesville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2222-2019