Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV

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

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.

On 01/02/2026, the firm emailed an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" Letter to customers informing them that Alphatec Spine has been notified of complaints regarding LIF Navigated Osteotome instruments appearing to have incorrect orientation when used with the Medtronic StealthStation". The instrument is correctly identified and displays the correct navigated length; however, the projected image on the Medtronic StealthStation" is rotated by 90. Customers are instructed to: "Review their inventory to determine if any of these affected devices are in their possession. If a device is within their possession, abstain from use and return the device to Alphatec Spine using the attached return label. "Share this notice within their organization or any organization where the affected device(s) has (have) been transferred. "Fill out the last page of this letter to confirm that they have read this notification and have taken all necessary actions, as described in this notification. For any questions/concerns or require assistance with the recall, e-mail QMSCompliance@atecspine.com or call 1-800-922-1356.

• FDA enforcement recordOfficial FDA database entry for Z-1343-2026
• FDA 510(k) clearance · K223765The device's official FDA premarket clearance record
• FDA device classification · OLOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Alphatec Spine, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.