ATEC Lateral Navigation Disc Prep Instruments LIF NAV — Class II medical device recall Z-1343-2026
Ongoing recall by Alphatec Spine, Inc., reported 2026-02-18, distributed nationwide. Due a design issue where the navigated array connection geometry is incorrect.
| Recall number | Z-1343-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2026-01-02 |
| Classified | 2026-02-11 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| UPC / GTIN / UDI-DI | 00190376541471 |
| Lot numbers | EM56693 |
| Model numbers | 267-01-000-10-N |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1343-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.