[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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