SEASPINE ORTHOPEDICS CORPORATION: Device Recall

Recall #Z-0937-2026 · 11/17/2025

Class II: Risk

Recall Details

Recall Number
Z-0937-2026
Classification
Class II
Product Type
Device
Recalling Firm
SEASPINE ORTHOPEDICS CORPORATION
Status
Ongoing
Date Initiated
11/17/2025
Location
Carlsbad, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
310

Reason for Recall

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.

Product Description

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

Distribution Pattern

US: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, AZ, MS, SC, UT, NY, OK, SD. OUS: Australia, Mexico, Chile

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.