Lower risk Medical device recall · FDA · Published November 17, 2025

SEASPINE NorthStar OCT Navigation Guide: Incorrect Compatibility Warning

SEASPINE recalls NorthStar OCT Navigation Surgical Technique Guide and instruments due to incorrect compatibility warnings with Medtronic systems. This could lead to improper use if the guide lists Infinity toolcards as compatible.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0937-2026Medical device SEASPINE ORTHOPEDICS ›

Lower-risk 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.

Take action

Contact the company

Recalling firmSEASPINE ORTHOPEDICS CORPORATION5770 Armada Dr · Carlsbad, CA 92008-4608

✎ GovInfoNow plain-language explainer

SEASPINE is recalling its NorthStar OCT Navigation Surgical Technique Guide and instruments because the guide incorrectly lists Medtronic Infinity toolcards as compatible with the instruments. This could cause improper surgical use if the guide is followed without checking compatibility. Read more at govinfonow.com/recall/50647-seaspine-northstar-oct-navigation-guide-incorrect-compatibility-warning.

Source Summary by GovInfoNow · govinfonow.com/recall/50647-seaspine-northstar-oct-navigation-guide-incorrect-compatibility-warning · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0937-2026

Cite this page

“SEASPINE NorthStar OCT Navigation Guide: Incorrect Compatibility Warning.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50647-seaspine-northstar-oct-navigation-guide-incorrect-compatibility-warning. Based on FDA recall #Z-0937-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0937-2026%22&limit=1).

The FDA announced on Nov. 17, 2025, that SEASPINE ORTHOPEDICS CORPORATION is recalling its Orthofix NorthStar OCT Navigation Surgical Technique Guide and related instruments due to incorrect compatibility identification. The company initiated this voluntary Class II recall after determining the guide falsely listed Medtronic Infinity system toolcards as compatible.

How to tell if you have it

Brand: SEASPINE ORTHOPEDICS
Product: Orthofix NorthStar OCT Navigation Surgical Technique Guide and instruments (Navigation Driver, Straight Bone Probe, Drills, Taps)
REF codes: PC2-400012, PC2-400013, PC2-400135, PC2-400140, PC2-400145, PC2-400155, PC2-400235, PC2-400240, PC2-400245, PC2-400345, PC2-400355
Lot codes: 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, AL657979C, AL658549C, AL658549CRRR, AL658641C, AL661470C, AL671917D, AL683456F, AL702785F, BK104899A, BK104899AR, BK104899ARR, BK104899ARRR, BK104899ARRR4, BK106822A, CR49020D, CR49023D, CR49060D, CR51550E, CR51972D, CR56472E, BK104900A, BK104900AR, BK104900ARRR, BK106825A, BK107806A, BK107806ARRR, BK108366A, BK108366ARRR, CR49822D, CR50158D, CR51973D, CR57547E, CR59411E, BK104901A, BK104901ARRR, BK106827A, CR49021C, CR49061C, CR51974C, BK104902A, BK104902ARRR, BK106829A, CR49062C, CR51551C, CR51975C, CR57550E, CR59413E, BK104903A, BK104903ARRR, BK106831A, BK106831ARRR, BK131159C, CR49620C, CR52371D, CR54729D, CR58013D, CR59414D, BK104904A, BK104904ARRR, BK106833A, BK131160C, CR49621C, CR52372D, CR59415D, BK104905A, BK104905ARRR, BK106834A, BK106834ARRR, BK131161C, CR49622C, CR52373D, BK104906A, BK106835A, CR51764C, CR52853D
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) and OUS (Australia, Mexico, Chile)

The hazard

The NorthStar OCT Navigation Surgical Technique Guide incorrectly identified both Medtronic's Solera and Medtronic's Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. The instruments are actually compatible for use with Medtronic's Solera toolcards only.

Context

GovInfoNow's records show SEASPINE ORTHOPEDICS CORPORATION has 8 other recalls on record since Feb. 15, 2024. Other recent recalls of similar products include SeaSpine Mariner Deformity Product Recall (Aug. 19, 2026), SeaSpine Polyaxial Head Recall (May 28, 2026), and SEASPINE Reef TA Inserter Recall (Aug. 6, 2025).

How to tell if you have this one

Check for the NorthStar OCT Navigation Surgical Technique Guide (STG) revisions D0003926A-D and instruments with reference numbers PC2-400012 to PC2-400355. The recall includes specific model numbers and lot codes listed in the record.

Brand
SEASPINE ORTHOPEDICS
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the product reference numbers and revisions listed in the recall notice to confirm if your items are affected.

Where it went and when

Where it was distributed

Distributed in 24 states, and outside the U.S.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Michigan, Mississippi, Missouri, Nevada, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Virginia, Washington.

Recall timeline

FDA published this recall 37 days after the firm started it.

Nov 17, 2025Firm started the recall
Dec 17, 2025FDA classified it Class II
Dec 24, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these products?

No, the recall does not require immediate discontinuation. However, you should verify compatibility before use.

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Link to this recall

<a href="https://govinfonow.com/recall/50647-seaspine-northstar-oct-navigation-guide-incorrect-compatibility-warning">SEASPINE NorthStar OCT Navigation Guide: Incorrect Compatibility Warning (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0937-2026 (November 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0937-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.