# FDA recall Z-1343-2026

> **Alphatec Spine, Inc.** · Class II · device recall initiated 2026-01-02.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1343-2026
- **Recalling firm:** Alphatec Spine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-02
- **Report date:** 2026-02-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1343-2026

## Citation

> AI Analytics. FDA recall Z-1343-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1343-2026. Source: US FDA. Licensed CC0.

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