Z-0542-2021 Class II Terminated

Recalled by K2M, Inc — Leesburg, VA

Recall Details

Product Type
Devices
Report Date
December 16, 2020
Initiation Date
November 4, 2020
Termination Date
February 22, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
197 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679