# FDA recall Z-0542-2021

> **K2M, Inc** · Class II · device recall initiated 2020-11-04.

## 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

## Distribution

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

## Key facts

- **Recall number:** Z-0542-2021
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-04
- **Report date:** 2020-12-16
- **Termination date:** 2024-02-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Leesburg, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0542-2021

## Citation

> AI Analytics. FDA recall Z-0542-2021. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-0542-2021. Source: US FDA. Licensed CC0.

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