Alphatec recalls specific LIF NAV Osteotome instruments due to incorrect navigated array connection geometry. This design issue may affect surgical procedures. Affected units have UDI-DI code 00190376476179.
Due a design issue where the navigated array connection geometry is incorrect.
Alphatec is recalling certain LIF NAV Osteotome 10mm surgical instruments because of a design flaw in the navigation connection geometry. This could lead to improper surgical guidance during procedures. The recall affects specific units with the UDI-DI code 00190376476179.
The instruments have an incorrect navigated array connection geometry, which could lead to improper surgical guidance during spinal procedures. This design issue might cause the instruments to function incorrectly when used with the Medtronic StealthStation System.
Surgical professionals using Alphatec's LIF NAV Osteotome 10mm instruments with UDI-DI code 00190376476179 are affected. The risk is highest for those performing spinal surgery with these instruments.
Check for the model number 266-01-000-10-N and UDI-DI code 00190376476179 on the instrument packaging or label. These instruments were sold with lot number EM49968.
Look for the model number 266-01-000-10-N and UDI-DI code 00190376476179 on the instrument packaging or label.
The recall is due to a design issue where the navigated array connection geometry is incorrect, which could affect surgical guidance during procedures.
The official notice does not specify a remedy or action steps for affected instruments.
The recall indicates a potential design issue that could affect surgical guidance, but the official notice does not specify if the instrument is safe to use without correction.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1342-2026 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1342-2026 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.