ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; G

FDA device recall Z-1342-2026 · posted 2026-02-11 · Open, Classified

Recall details

Recalling firm

Alphatec Spine, Inc.

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

OLO

Quantity affected

7 units

Distribution

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

Date initiated

2026-01-02

Date posted

2026-02-11

Location

Carlsbad, CA

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