--- title: "Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: ... — FDA record Z-0937-2026 | Is It on Recall" description: "The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatib" url: https://isitonrecall.com/recall/fda-device-z-0937-2026-orthofix-northstar-oct-navigation-surgical-technique-guide-and-instruments-navigation-driver-ref-pc2/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navi... — FDA record Z-0937-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Nov 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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 - **Recalling firm**: SEASPINE ORTHOPEDICS CORPORATION - **Quantity**: 310 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0937-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0937-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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 | Match all identifying details in the current notice. A brand name alone is not enough. ## 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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alabama](https://isitonrecall.com/state/alabama/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Florida](https://isitonrecall.com/state/florida/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Washington](https://isitonrecall.com/state/washington/) ## Dates in the source - **Report date**: Dec 24, 2025 - **Recall initiation date**: Nov 17, 2025 - **Center classification date**: Dec 17, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0937-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [SEASPINE ORTHOPEDICS CORPORATION records](https://isitonrecall.com/brand/seaspine-orthopedics-corporation/)