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Alphatec Spine Lateral Navigation Disc Prep Instruments
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MEDICAL DEVICE RECALLMODERATE

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.

What to do

Healthcare facilities should immediately discontinue use of the affected instruments and contact Alphatec Spine for return and replacement instructions.

Recalled
Listed
Updated
Recall No.
Z-1343-2026
Agency
FDA
Firm
Alphatec Spine, Inc.
Recall ID
98251
Status
ONGOING

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.

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF

ProductRecall #
267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep InstrumentsZ-1343-2026
266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep InstrumentsZ-1342-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification