Recall Z-1343-2026— Alphatec Spine, Inc.

Name: FDA recall Z-1343-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-02

Class II · Ongoing

Class II FDA medical device recall by Alphatec Spine, Inc., initiated 2026-01-02. It names one FDA 510(k) clearance: K223765. Product: ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; 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.. Reason: Due a design issue where the navigated array connection geometry is incorrect..

Recalling firm: Alphatec Spine, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-01-02
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K223765 — ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.·cleared 2023-03-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.