FDA Device recall Z-1342-2026
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179
- FDA Device
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179 by Alphatec Spine, citing due a design issue where the navigated array connection geometry is incorrect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1342-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-02 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Alphatec Spine |
| Distribution | US |
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
Due a design issue where the navigated array connection geometry is incorrect.
Identifiers
| code_info | Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1342-2026%22
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