K2M, Inc recalls Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by roc…

Recall date

November 4, 2020

Source

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

Recall number

Z-0542-2021

FDA classification

Class II

Brand / firm

K2M, Inc

Sold / distributed

Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden

Why it was recalled

All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks

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

What was recalled

Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195