Lower riskMedical device recall · FDA · Published January 2, 2026
Alphatec LIF NAV Osteotome 10mm: Incorrect Navigation Geometry Risk
Alphatec recalls specific LIF NAV Osteotome 10mm instruments due to incorrect navigated array connection geometry. These surgical tools may not function properly with Medtronic StealthStation systems.
“Alphatec LIF NAV Osteotome 10mm: Incorrect Navigation Geometry Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50325-alphatec-lif-nav-osteotome-10mm-incorrect-navigation-geometry-risk. Based on FDA recall #Z-1343-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1343-2026%22&limit=1).
Alphatec Spine, Inc. voluntarily recalled ATEC Lateral Navigation Disc Prep Instruments due to a design issue with the navigated array connection geometry, according to the FDA on Jan. 2, 2026.
The recall is due to a design issue where the navigated array connection geometry is incorrect, according to the FDA.
Context
GovInfoNow's records show Alphatec Spine, Inc. has 6 other recalls on record since April 26, 2021. Other recent recalls of similar products include GE Medical Systems Imactis CT-Navigation System Recall (Feb. 3, 2026), XTANT Medical Xpress Pedicle Screw System (Feb. 18, 2026), and Canon Vantage Galan 3T Medical Device Recall (Oct. 16, 2025).
How to tell if you have this one
Check for the model number 267-01-000-10-N and UDI-DI code 00190376541471 on the instruments. These instruments were sold with lot number EM56693.
Brand
Alphatec
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
Recall number
Product, codes & lots
Quantity
Z-1342-2026
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.; Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
7 units
Z-1343-2026
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.; Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693
15 units
Based on the official FDA remedy
What to do — step by step
Check Instrument Details
Verify the model number and UDI-DI code on the instruments to confirm if they are affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, New Hampshire, New York, North Carolina, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1343-2026 (January 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1343-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.