Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigat

FDA device recall Z-0937-2026 · posted 2025-12-17 · Open, Classified

Recall details

Recalling firm

SEASPINE ORTHOPEDICS CORPORATION

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.

Action taken

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

Root cause

Labeling design

Status

Open, Classified

Product code

OLO

Quantity affected

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

Date initiated

2025-11-17

Date posted

2025-12-17

Location

Carlsbad, CA

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