Alphatec Spine Lateral Navigation Disc Prep Instruments
Alphatec Spine is recalling 10mm Osteotome navigation instruments due to a design flaw in the array connection geometry.
Healthcare facilities should immediately discontinue use of the affected instruments and contact Alphatec Spine for return and replacement instructions.
Why it was recalled
Alphatec Spine is recalling the Lateral Navigation Disc Prep Instruments, specifically the 10mm Osteotome, due to a design issue where the navigated array connection geometry is incorrect. This defect may prevent the instrument from properly connecting to the navigation system during surgical procedures.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| 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. | 00190376541471 | Z-1343-2026 |
| 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. | 00190376476179 | Z-1342-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Alphatec Spine, Inc.
Editorial summary by Recall Canary · last updated 2026-06-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification