FDAHealthJanuary 2, 2026
Alphatec Spine, Inc. — 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
⚠️ Due a design issue where the navigated array connection geometry is incorrect.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 2, 2026
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
What's affected?
- 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-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
- Brand
- Alphatec Spine, Inc.
- Lot code
- EM49968
Additional details
Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.