Lower risk Medical device recall · FDA · Published November 4, 2020

K2M Everest MI XT Tab Removal Tool Recall: Cracking Risk from Loctite Leakage

K2M recalls Everest MI XT Tab Removal Tools due to cracking at the metal shaft and handle interface, which may cause Loctite leakage. Affected units have specific catalog and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0542-2021Medical device K2M ›

Lower-risk 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

Take action

Contact the company

Recalling firmK2M, Inc600 Hope Pkwy SE · Leesburg, VA 20175-4428

✎ GovInfoNow plain-language explainer

K2M is recalling Everest MI XT Tab Removal Tools because they can crack at the metal shaft and handle connection, leading to Loct: leakage. This could cause the tool to fail during use, potentially causing leaks or damage to the Everest XT screw. Read more at govinfonow.com/recall/63983-k2m-everest-mi-xt-tab-removal-tool-recall-cracking-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63983-k2m-everest-mi-xt-tab-removal-tool-recall-cracking-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0542-2021

Cite this page

“K2M Everest MI XT Tab Removal Tool Recall: Cracking Risk from Loctite Leakage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63983-k2m-everest-mi-xt-tab-removal-tool-recall-cracking-risk. Based on FDA recall #Z-0542-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0542-2021%22&limit=1).

The FDA announced on November 4, 2020, that K2M, Inc. voluntarily recalled Everest MI XT Tab Removal Tools due to potential leakage of Loctite from handle cracks. The agency issued recall number Z-0542-2021 for the Class II device.

How to tell if you have it

K2M Everest MI XT Tab Removal Tool (All-In-One Tab Removal Tool)
Catalog number: 5101-90195
Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR
UPC: 10888857290679

The hazard

The All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between the tool's metal shaft component and handle. This defect can result in leakage of Loctite from handle cracks.

Context

GovInfoNow's records show K2M, Inc. has had 10 other recalls on record since July 24, 2018. Other recent recalls of similar products include Medline Nerve Block Tray 2 Kits Recall (December 12, 2025), Olympus Thunderbeat II Shears Recall (March 23, 2026), and Stryker AHTO Tube Set Leaking During Use - Recall (June 8, 2026).

How to tell if you have this one

Check for catalog number 5101-90195 and lot numbers JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR. The tool is used to break tabs off Everest XT screws by rocking it back and forth.

Brand
K2M
Product
K2M, Inc recalls 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
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Catalog Number
Verify the catalog number 5101-90195 on the tool's label.
Check Lot Numbers
Confirm the lot numbers JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, or MAJR are on the tool.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.3 years after the firm started it.

Nov 4, 2020Firm started the recall
Dec 7, 2020FDA classified it Class II
Dec 16, 2020Published in FDA’s Enforcement Report
Feb 22, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the Everest MI XT Tab Removal Tool used for?

It is 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.

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Link to this recall

<a href="https://govinfonow.com/recall/63983-k2m-everest-mi-xt-tab-removal-tool-recall-cracking-risk">K2M Everest MI XT Tab Removal Tool Recall: Cracking Risk from Loctite Leakage (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0542-2021 (November 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0542-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.