Device product
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
Z-0542-2021
Product summary
- Firm
- K2M, Inc
- Event
- Event 86733
- Status
- Terminated
- Classification
- Class II
- Quantity
- 197 units
- Official record key
device-enforcement:Z-0542-2021
Official wording
Reason: 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
Code information: Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679
Distribution pattern: Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden
Derived failure modes
-
Unknown
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