K2M, Inc: Medical Device Recall in 2020 - (Recall #: Z-0542-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 4, 2020

Date Posted: December 16, 2020

Recall Number: Z-0542-2021

Event ID: 86733

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

Status: Terminated

Product Quantity: 197 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated