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Z-1342-2026Class II

Alphatec Spine, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Alphatec Spine, Inc.
Product type
Device
Status
Ongoing
Report date
2026-02-18
Distribution
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
Firm state
CA
Product quantity
7 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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.

Code / lot info

Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968

Other recalls SPEQ maps to Documentation & Change Control
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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →