Orthofix NorthStar OCT Navigation Surgical Technique Guide — Class II medical device recall Z-0937-2026

Ongoing recall by SEASPINE ORTHOPEDICS CORPORATION, reported 2025-12-24, distributed in AL, AZ, CA, CO, CT, FL, IL, IN…. The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and

Recall number	`Z-0937-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA, United States
Recall initiated	2025-11-17
Classified	2025-12-17
Reported by FDA	2025-12-24
Distributed	AL, AZ, CA, CO, CT, FL, IL, IN, MI, MO, MS, NJ, NV, NY, OK, OR, PA, RI, SC, SD, TX, UT, VA, WA
Countries outside the US	AU, CL, MX
Quantity	310
UPC / GTIN / UDI-DI	`10889981260033`, `10889981260040`, `10889981260057`, `10889981260064`, `10889981260071`, `10889981260088`, `10889981260095`, `10889981260101`, `10889981260118`, `10889981260125`, `10889981275495`
Lot numbers	`AL658549C`, `AL658549CRRR`, `AL658641C`, `AL661470C`, `AL671917D`, `AL683456F`, `AL702785F`, `BK104899AR`, `BK104899ARR`, `BK104899ARRR`, `BK104899ARRR4`, `BK104900AR`, `BK104900ARRR`, `BK104901ARRR`, `BK104902ARRR`, `BK104903ARRR`, `BK104904ARRR`, `BK106822A`, `BK106825A`, `BK106827A`, `BK106829A`, `BK106831A`, `BK106831ARRR`, `BK106833A`, `BK107806A`, `BK107806ARRR`, `BK108366A`, `BK108366ARRR`, `BK131159C`, `BK131160C`, `CR49020D`, `CR49021C`, `CR49023D`, `CR49060D`, `CR49061C`, `CR49062C`, `CR49620C`, `CR49621C`, `CR49822D`, `CR50158D` and 49 more
Model numbers	`PC2-400012`, `PC2-400013`, `PC2-400135`, `PC2-400140`, `PC2-400155`, `PC2-400235`, `PC2-400240`, `PC2-400245`, `PC2-400345`, `PC2-400355`

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0937-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.