Reported Dec 16, 2020 · Terminated

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…

K2M, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: K2M, Inc · 600 Hope Pkwy SE · Leesburg, VA · 20175-4428

Is this the product you have?

  • 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 number5101-90195
Lot codes and dates
  • Lot NumbersJUFT, JUGX, KEFE, KUBJ, KVNT, KYRR
  • MAJR GTIN10888857290679
Amount recalled
197 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 22, 2024 · Data as of Sep 19, 5:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.