Orthofix NorthStar OCT Navigation Surgical Technique recall
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF…
Why was Orthofix NorthStar OCT Navigation Surgical Technique recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF…
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Quantity
- 310
- 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
- Recall date
- December 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)