FDA recall, , Moderate risk
ATEC Lateral Navigation Disc Prep Instruments
ATEC Lateral Navigation Disc Prep Instruments have a design issue with incorrect navigated array connection geometry.
Summary by Recall Canary from the FDA notice
What happened
Alphatec Spine, Inc., of Carlsbad, California, recalled certain ATEC Lateral Navigation Disc Prep Instruments LIF NAV OSTEOTOME 10mm instruments because of a design issue where the navigated array connection geometry is incorrect. The FDA added the recall to its Enforcement Report on February 11, 2026.
The instruments, intended for use in surgical procedures with the Medtronic StealthStation System and NavLock Tracker, were distributed in Arizona, California, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Tennessee, Texas and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
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
- UDI-DI
- 00190376541471
- Lot code
- EM56693
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
- UDI-DI
- 00190376476179
- Lot code
- EM49968
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Arizona, California, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Tennessee, Texas, and Virginia.
- Company
- Alphatec Spine, Inc.Carlsbad, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98251
- Recall numbers
- Z-1342-2026 to Z-1343-2026
All recalls from Alphatec Spine, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
