The Recall Desk

FDA (Devices) recall action 98251

Alphatec Spine, Inc. recalled 2 products on 2026-02-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-02-18
Critical
0
Units
22

Why these products were recalled

Due a design issue where the navigated array connection geometry is incorrect.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2026-02-18

    Spinal navigation instruments recalled over incorrect array connection geometry

    Alphatec Spine is recalling 15 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

    Product
    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-
    Category
    Distribution
    14 states
  • ModerateFDA (Devices)··2026-02-18

    Navigation osteotomes recalled over incorrect array connection geometry

    Alphatec Spine is recalling 7 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

    Product
    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-
    Category
    Distribution
    14 states