FDA-Device2020-12-16Class II
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
K2M, Inc
Hazard
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
Sold states
Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden
Affected count
197 units
Manufactured in
600 Hope Pkwy SE, N/A, Leesburg, VA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0542-2021Don't want to check this manually?
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