Everest MI XT Tab Removal Tool — Class II medical device recall Z-0542-2021
Terminated recall by K2M, Inc, reported 2020-12-16, distributed nationwide. All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s meta
| Recall number | Z-0542-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2020-11-04 |
| Classified | 2020-12-07 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2024-02-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, ES, GB, IT, NL, NO, SE |
| Quantity | 197 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10888857290679 |
| Model numbers | 5101-90195 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0542-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.