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Class IIOngoingZ-0937-2026

SEASPINE ORTHOPEDICS CORPORATION recalls Orthofix NorthStar OCT Navigation Surgical Technique Guide

SEASPINE ORTHOPEDICS CORPORATIONCarlsbad, CA, United StatesReported Dec 24, 2025 · 6 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver1 code
  • PC2-400012
Navigation Straight Bone Probe1 code
  • PC2-400013
Navigation, 3.5mm Drill1 code
  • PC2-400135
Navigation, 4.0mm Drill1 code
  • PC2-400140

Navigation, 4.5mm Drill, PC2-400145

Navigation, 5.5mm Drill1 code
  • PC2-400155
Navigation, 3.5mm Tap1 code
  • PC2-400235
Navigation, 4.0mm Tap1 code
  • PC2-400240
Navigation, 4.5mm Tap1 code
  • PC2-400245
Navigation, 4.5mm Dual Lead Tap1 code
  • PC2-400345
Navigation, 5.5mm Dual Lead Tap1 code
  • PC2-400355

Lot / code information

Lot #
PC2-400012/10889981260033/MK81527A, MK81527ARR, MK81527ARRR, MK81574AR, MK81574AR1, MK93487A — +93 moreShow all
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

What the firm is doing

On 10/27/2025, device correction notices were emailed to customers who were informed of the following: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic's Solera and Medtronics Infinity system StealthStation tool cards as compatible with the NorthStar OCT Navigation Instruments; however, the NorthStar OCT Navigation Instruments are indicated for use with Medtronic's Solera tool cards only. 1) Discontinue use of Medtronic's Infinity tool cards with NorthStar OCT Navigation instruments. 2) Discard affected version of the Surgical Technique Guide 3) This notice should be shared within your organization and forwarded to any organization where affected Instruments and guide is utilized. 4) Review updated Surgical Technique Guide D0003926 Revision DA. This notice should be shared within your organization and forwarded to any organization where affected instruments are utilized. Any product complaints should be reported to Orthofix at complaints@orthofix.com

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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