CLASS II ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report

Atec Lateral Navigation Disc Prep Instruments Lif Nav, Osteotome recalled

Alphatec Spine is recalling Atec Lateral Navigation Disc Prep Instruments Lif Nav, Osteotome, distributed nationwide in the US. The recall was initiated on 2 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693

Quantity recalled15 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1343-2026
FDA event ID: 98251
Recalling firm: Alphatec Spine, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Jan 2026
FDA classified: 11 Feb 2026
Reported: 18 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

2 Jan 2026	Recall initiated by company
11 Feb 2026	Classified by FDA	+40 days
18 Feb 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arizona California Florida Illinois Indiana Massachusetts Michigan Missouri North Carolina New Hampshire New York Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98251

Reported	Class	Recall	Company	Reason	Where
18 Feb 2026	CLASS II	Atec Lateral Navigation Disc Prep Instruments Lif Nav, Osteotome recalled	Alphatec Spine	Packaging Defects	Nationwide

More recalls from Alphatec Spine

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29 Jul 2026Device	CLASS II	SafeOp Patient Interface recalled by Alphatec Spine	Alphatec Spine	Device Malfunction	Nationwide
18 Feb 2026Device	CLASS II	Atec Lateral Navigation Disc Prep Instruments Lif Nav, Osteotome recalled	Alphatec Spine	Packaging Defects	Nationwide
5 Feb 2025Device	CLASS II	Calibrate CCX Interbody System for spinal fusion procedures recalled	Alphatec Spine	Other	Nationwide
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