ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;
Summary
The FDA issued a Class II for ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-0 by Alphatec Spine, Inc.. Reason: Due a design issue where the navigated array connection geometry is incorrect..
Details
Source
Device Recall
External ID
Z-1342-2026
Action Date
2026-02-18
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
Quantity Affected: 7 units
Reason for Recall
Due a design issue where the navigated array connection geometry is incorrect.
Distribution
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-02
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Alphatec Spine, Inc. has 41 FDA actions in our database, including 6 recalls and 35 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alphatec Spine, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alphatec Spine, Inc. have FDA actions?
Alphatec Spine, Inc. has 41 FDA actions in our database, including 6 recalls and 35 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1342-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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