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Home › FDA recalls › ATEC Lateral Navigation Disc Prep Instruments LIF NAV
CLASS II · ModerateFDA

Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV

📅 Jan 2, 2026 · 📍 Nationwide
Recalling company
Alphatec Spine, Inc.
Product
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.
Reason
Due a design issue where the navigated array connection geometry is incorrect.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jan 2, 2026
Reported
Feb 18, 2026
Distribution
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
Status
Ongoing
Quantity
7 units
Lot / codes
Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
Company location
Carlsbad, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-1342-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1342-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.