Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Orthofix NorthStar OCT Navigation Surgical Technique Guide Recalled by SEASPINE ORTHOPEDICS CORPORATION Due to The NorthStar OCT Navigation Surgical Technique Guide (STG)...

Date: November 17, 2025
Company: SEASPINE ORTHOPEDICS CORPORATION
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SEASPINE ORTHOPEDICS CORPORATION directly.

Affected Products

Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400240; Navigation, 4.5mm Tap, REF: PC2-400245; Navigation, 4.5mm Dual Lead Tap, REF: PC2-400345; Navigation, 5.5mm Dual Lead Tap, REF: PC2-400355

Quantity: 310

Why Was This Recalled?

The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.

Where Was This Sold?

This product was distributed to 24 states: AL, AZ, CA, CO, CT, FL, IL, IN, MI, MS, MO, NV, NJ, NY, OK, OR, PA, RI, SC, SD, TX, UT, VA, WA

Affected (24 states)Not affected

About SEASPINE ORTHOPEDICS CORPORATION

SEASPINE ORTHOPEDICS CORPORATION has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report