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FDA (Device enforcement)Recalled 2020-11-04closedclass ii

K2M, Inc: 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 detach

Is my product affected?

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

  • UPC 10888857290679

Check against the official notice below — it lists the full affected range.

What happened

K2M, Inc. is recalling the Everest MI XT Tab Removal Tool, an all-in-one instrument used to break tabs off Everest XT screws by rocking the device back and forth. The tool may crack and separate at the threaded interface where the metal shaft connects to the handle, which can cause Loctite to leak from cracks in the handle. A total of 197 units have been distributed nationwide and in eight foreign countries: the Netherlands, Spain, the United Kingdom, Belgium, Germany, Italy, Norway, and Sweden. The affected lot numbers are JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, and MAJR.

The source document does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Quantity: 197 units Lot/code info: Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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