Alphatec Spine, Inc.: ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The A

Company / brand

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 / hazard

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

Classification

Class II

Status

Ongoing

Distribution / sold at

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

Recall initiated

2026-01-02

Code info

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

Product quantity

7 units

Voluntary mandated

Voluntary: Firm initiated

City

Carlsbad

State

CA

Country

United States

Event id

98251

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