ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI c
Pending LLM rewrite. Source: FDA_DEVICE Z-1343-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Due a design issue where the navigated array connection geometry is incorrect.
The recalled product
- 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-
- Manufacturer
- Alphatec Spine, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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