Z-1343-2026 Class II Ongoing
FDA device recall Z-1343-2026 was initiated by Alphatec Spine, Inc. on January 2, 2026 and is designated Class II. Reason for recall: Due a design issue where the navigated array connection geometry is incorrect. The recall status is ongoing. Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2026
- Initiation Date
- January 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
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-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Reason for Recall
Due a design issue where the navigated array connection geometry is incorrect.
Distribution Pattern
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
Code Information
Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693