ATEC Lateral Navigation Disc Prep Instruments LIF NAV recalled over sterility concerns

Recall date

January 2, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;…

Recall number

Z-1342-2026

FDA classification

Class II

Brand / firm

Alphatec Spine, Inc.

Sold / distributed

U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.

Why it was recalled

Due a design issue where the navigated array connection geometry is incorrect.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.