Alphatec Spine Recalls ATEC Lateral Navigation Disc Prep Instruments Due to Design Flaw
Alphatec Spine, Inc. is recalling 15 units of its ATEC Lateral Navigation Disc Prep Instruments because of incorrect connection geometry that could impact surgical navigation systems.
What Happened
Alphatec Spine, Inc. has initiated a voluntary recall of its ATEC Lateral Navigation Disc Prep Instruments. The recall was prompted by a design issue where the navigated array connection geometry was found to be incorrect. These instruments are designed to function with the Medtronic StealthStation System and NavLock Tracker during surgical procedures.
Which Products Are Affected
The recall affects 15 units of the following product:
- Product Name: ATEC Lateral Navigation Disc Prep Instruments (LIF NAV, OSTEOTOME 10mm)
- Model/Catalog Number: 267-01-000-10-N
- UDI-DI Code: 00190376541471
- Lot Number: EM56693
- Recall Number: Z-1343-2026
The affected units were distributed nationwide across the following states: Arizona, California, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Tennessee, Texas, and Virginia.
What You Should Do
Alphatec Spine, Inc. initiated the recall on January 2, 2026, and notified affected customers via a formal letter. Healthcare providers and facilities possessing these instruments should follow the instructions provided in the firm’s notification regarding the return or correction of the affected devices.
Why This Matters
This is a Class II recall, which indicates that the use of the defective product may cause temporary or medically reversible adverse health consequences. The incorrect geometry in the navigation connection could potentially lead to inaccuracies during surgical procedures.
Source
Information provided by the FDA.
Source: FDA Official Notice