BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0937-2026 · Initiated November 17, 2025

    Recall

    Recall Number
    Z-0937-2026
    Event Number
    97973
    Firm
    SEASPINE ORTHOPEDICS CORPORATION
    FEI Number
    3012120772
    Product Code
    OLO
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    November 17, 2025
    Posted
    December 17, 2025
    Address
    5770 Armada Dr, Carlsbad, CA, 92008-4608

    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

    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.

    Action

    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 [email protected]

    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

    Quantity

    310