FDA Medical devices recall ·
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm recall
- Recall number
- Z-1342-2026
- Date
- (initiated January 2, 2026)
- Company / brand
- Alphatec Spine, Inc.
1950 Camino Vida Roble, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due a design issue where the navigated array connection geometry is incorrect.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
Distribution
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
States: Arizona California Florida Illinois Indiana Massachusetts Michigan Missouri North Carolina New Hampshire New York Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1342-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.