Z-1343-2026Class II

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code...

Name: Z-1343-2026 ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code...
Creator: Alphatec Spine, Inc.
Published: 2026-01-02
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2026-01-02 / Open, Classified / root cause: design

FDA source

Alphatec Spine, Inc. began a recall of 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... on 2026-01-02. FDA classified it as Class II and gives the reason as "Due a design issue where the navigated array connection geometry is incorrect". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1343-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-02
Posted: 2026-02-11
Recalling firm: Alphatec Spine, Inc.
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.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Due a design issue where the navigated array connection geometry is incorrect.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected] or call 1-800-922-1356.
Quantity in commerce: 15 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.
Product codes and lots: Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1343-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1342-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11
Z-1343-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11

Product code OLO

K223765Class IIATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. / cleared 2023-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)