ATEC Lateral Navigation Disc Prep Instruments recallZ-1342-2026 · Alphatec Spine, Inc. · initiated Jan 2, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alphatec Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due a design issue where the navigated array connection geometry is incorrect.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1342-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 2, 2026
- Posted by the FDA
- Feb 11, 2026
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 7 units
- Product code
- OLO
- FDA submissions
- K223765
- 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 description
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.
Code information (models, lots, serial numbers)
Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ATEC Lateral Navigation Disc Prep Instruments 266-01-000-10-NAlphatec Spine, Inc. · Orthopedic stereotaxic instrument1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K223765 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ATEC Lateral Navigation Disc Prep Instruments 267-01-000-10-NAlphatec Spine, Inc. · Orthopedic stereotaxic instrument1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98251).
- Z-1343-2026 · Open, ClassifiedATEC 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 int…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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