ATEC Lateral Navigation Disc Prep Instruments LIF NAV recall (Alphatec Spine, Inc.)
Medical deviceClass IIOngoing
Summary: Alphatec Spine, Inc. is recalling 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. Reason: Due a design issue where the navigated array connection geometry is incorrect.
What is being recalled
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.
Why
Due a design issue where the navigated array connection geometry is incorrect.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA. (states named: Arizona, California, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Tennessee, Texas, Virginia)
How to tell if yours is affected
Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1342-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 2, 2026 |
| Reported | February 18, 2026 |
| Company | Alphatec Spine, Inc. |
| Company location | Carlsbad, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 units |
More recalls from Alphatec Spine, Inc. · all medical device recalls · recalls from January 2026