CLASS II · ModerateFDA

SEASPINE ORTHOPEDICS CORPORATION recalls Orthofix NorthStar OCT Navigation Surgical Technique Guide

📅 Nov 17, 2025 · 📍 AL, AZ, CA, CO, CT, FL, IL, IN +16

Recalling company: SEASPINE ORTHOPEDICS CORPORATION
Product: 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
Reason: 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.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: Nov 17, 2025
Reported: Dec 24, 2025
Distribution: 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
Status: Ongoing
Quantity: 310
Lot / codes: Surgical Technique Guide revisions: D0003926A, D0003926B, D0003926C, D0003926D. REF/UDI-DI/Lot: PC2-400012/10889981260033/MK81527A, MK81527ARR, MK81527ARRR, MK81574AR, MK81574AR1, MK93487A, MK93488ARR, MK93489A, MK93490A, MK93490ARR, MK93491AR, MK93491AR1, MK943488A, MK95882A, MK95882ARR, ML52083B, ML53136B, ML53188B, ML69777B, ML69778B, ML71257B, MM1001498D, MM1001499D, MM1001748D, MM1001749D, MM1001813D, MM1001902D, MM1001903D, MM1002025D, MM1002316D, MM1002328D, MM1002344D; PC2-400013/10889981260040/AL657979C, AL658549C, AL658549CRRR, AL658641C, AL661470C, AL671917D, AL683456F, AL702785F; PC2-400135/10889981260057/BK104899A, BK104899AR, BK104899ARR, BK104899ARRR, BK104899ARRR4, BK106822A, CR49020D, CR49023D, CR49060D, CR51550E, CR51972D, CR56472E; PC2-400140/10889981260064/BK104900A, BK104900AR, BK104900ARRR, BK106825A, BK107806A, BK107806ARRR, BK108366A, BK108366ARRR, CR49822D, CR50158D, CR51973D, CR57547E, CR59411E; PC2-400145/10889981260071/BK104901A, BK104901ARRR, BK106827A, CR49021C, CR49061C, CR51974C; PC2-400155/10889981260088/BK104902A, BK104902ARRR, BK106829A, CR49062C, CR51551C, CR51975C, CR57550E, CR59413E; PC2-400235/10889981260095/BK104903A, BK104903ARRR, BK106831A, BK106831ARRR, BK131159C, CR49620C, CR52371D, CR54729D, CR58013D, CR59414D; PC2-400240/10889981260101/BK104904A, BK104904ARRR, BK106833A, BK131160C, CR49621C, CR52372D, CR59415D; PC2-400245/10889981275495/no lots released; PC2-400345/10889981260118/BK104905A, BK104905ARRR, BK106834A, BK106
Company location: Carlsbad, CA
Recall type: Voluntary: Firm initiated
Recall number: Z-0937-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0937-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.