Alphatec recalls specific LIF NAV Osteotome 10mm instruments due to incorrect navigated array connection geometry. These surgical tools may not function properly with Medtronic StealthStation systems.
Due a design issue where the navigated array connection geometry is incorrect.
Alphatec is recalling a specific model of surgical instruments for spinal procedures because their navigation geometry is incorrect. This could lead to improper surgical guidance when used with Medtronic StealthStation systems.
The instruments have an incorrect navigated array connection geometry, which means they may not function properly with Medtronic StealthStation systems. This could lead to improper surgical guidance during spinal procedures.
Surgical teams using Alphatec's LIF NAV Osteotome 10mm instruments with Medtronic StealthStation systems. Patients undergoing spinal surgery are most at risk if the instruments are used incorrectly.
Check for the model number 267-01-000-10-N and UDI-DI code 00190376541471 on the instruments. These instruments were sold with lot number EM56693.
Verify the model number and UDI-DI code on the instruments to confirm if they are affected.
The recall states there is a design issue with the navigation geometry, so they should not be used until the remedy is applied.
The recall does not specify a remedy, so you should check with Alphatec directly for guidance.
Look for the model number 267-01-000-10-N and UDI-DI code 00190376541471 on the instruments.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1343-2026 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1343-2026 from Alphatec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.