Alphatec Spine Recalls ATEC Lateral Navigation Disc Prep Instruments Due to Design Flaw

Source: FDA · United States

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Alphatec Spine, Inc. is recalling 15 units of its ATEC Lateral Navigation Disc Prep Instruments because of incorrect connection geometry that could impact surgical navigation systems.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 25, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Alphatec Spine, Inc. has initiated a voluntary recall of its ATEC Lateral Navigation Disc Prep Instruments. The recall was prompted by a design issue where the navigated array connection geometry was found to be incorrect. These instruments are designed to function with the Medtronic StealthStation System and NavLock Tracker during surgical procedures.

Which Products Are Affected

The recall affects 15 units of the following product:

  • Product Name: ATEC Lateral Navigation Disc Prep Instruments (LIF NAV, OSTEOTOME 10mm)
  • Model/Catalog Number: 267-01-000-10-N
  • UDI-DI Code: 00190376541471
  • Lot Number: EM56693
  • Recall Number: Z-1343-2026

The affected units were distributed nationwide across the following states: Arizona, California, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Tennessee, Texas, and Virginia.

What You Should Do

Alphatec Spine, Inc. initiated the recall on January 2, 2026, and notified affected customers via a formal letter. Healthcare providers and facilities possessing these instruments should follow the instructions provided in the firm's notification regarding the return or correction of the affected devices.

Why This Matters

This is a Class II recall, which indicates that the use of the defective product may cause temporary or medically reversible adverse health consequences. The incorrect geometry in the navigation connection could potentially lead to inaccuracies during surgical procedures.

Source

Information provided by the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Alphatec Spine, Inc. is recalling 15 units of its ATEC Lateral Navigation Disc Prep Instruments because of incorrect connection geometry that could impact surgical navigation systems.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.