The Recall Desk
ModerateFDA (Devices)·Z-1343-2026·Announced 2026-02-18

Spinal navigation instruments recalled over incorrect array connection geometry

Alphatec Spine is recalling 15 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites an incorrect array connection geometry with no stated consequence or reported harm.

Plain-English summary

The ATEC Lateral Navigation Disc Prep Instruments, LIF NAV Osteotome 10mm, REF 267-01-000-10-N, are being recalled by Alphatec Spine, Inc. The record states the instruments are intended for use in surgical procedures and are designed to function with the Medtronic StealthStation System and NavLock Tracker.

The reason given in the enforcement record is a design issue where the navigated array connection geometry is incorrect.

The record lists 15 units under model/catalog number 267-01-000-10-N, UDI-DI 00190376541471, lot number EM56693. Distribution was nationwide in the United States across the states listed in the enforcement record. The FDA has classified the action as Class II.

The record names no consequence and reports no injuries. Facilities should quarantine the affected lot and follow Alphatec's instructions.

The recalled product

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-
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical navigation instrument
Hazard
Affected units
15

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Alphatec Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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