CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report

Everest MI XT Tab Removal Tool (i.e recalled by K2M

K2M is recalling Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab, distributed nationwide in the US. The recall was initiated on 4 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679

Quantity recalled197 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0542-2021
FDA event ID: 86733
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Terminated
Recall initiated: 4 Nov 2020
FDA classified: 7 Dec 2020
Reported: 16 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

4 Nov 2020	Recall initiated by company
7 Dec 2020	Classified by FDA	+33 days
16 Dec 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it 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

Which lots are affected?

Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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