Recall Z-1343-2026
Alphatec Spine, Inc. · initiated January 2, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693
Reason for recall
Due a design issue where the navigated array connection geometry is incorrect.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1343-2026
- Initiated
- January 2, 2026
- Posted by FDA
- February 11, 2026
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Quantity
- 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.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1342-2026 Class II | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF…Due a design issue where the navigated array connection geometry is incorrect. | 01/02/2026Open, Classified |