Recall Z-0542-2021— K2M, Inc
Class II · Terminated
Class II FDA medical device recall by K2M, Inc, initiated 2020-11-04, terminated 2024-02-22. FDA's recall record names no specific 510(k) clearance for this event. 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. 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.
- Recalling firm
- K2M, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-04
- Terminated
- 2024-02-22
- Firm location
- Leesburg, VA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.