Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Naviga
Summary
The FDA issued a Class II for Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Na by SEASPINE ORTHOPEDICS CORPORATION. Reason: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards a.
Details
Source
Device Recall
External ID
Z-0937-2026
Action Date
2025-12-24
Status
Ongoing
Category
device
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
Lot/Code Info: 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, BK106834ARRR, BK131161C, CR49622C, CR52373D, CR54208D; PC2-400355/10889981260125/BK104906A, BK106835A, CR51764C, CR52853D
Quantity Affected: 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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-17
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SEASPINE ORTHOPEDICS CORPORATION has 30 FDA actions in our database, including 9 recalls and 21 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SEASPINE ORTHOPEDICS CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SEASPINE ORTHOPEDICS CORPORATION have FDA actions?
SEASPINE ORTHOPEDICS CORPORATION has 30 FDA actions in our database, including 9 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0937-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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