Reported Dec 24, 2025 · Ongoing
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments
Seaspine Orthopedics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SEASPINE ORTHOPEDICS CORPORATION · 5770 Armada Dr · Carlsbad, CA · 92008-4608
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Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments
11 products · 103 lot codes
PC2-400012Navigation Driver
- UDI-DI
10889981260033
32 recalled lot codes
MK81527AMK81527ARRMK81527ARRRMK81574ARMK81574AR1MK93487AMK93488ARRMK93489AMK93490AMK93490ARRMK93491ARMK93491AR1MK943488AMK95882AMK95882ARRML52083BML53136BML53188BML69777BML69778BML71257BMM1001498DMM1001499DMM1001748DMM1001749DMM1001813DMM1001902DMM1001903DMM1002025DMM1002316DMM1002328DMM1002344D
PC2-400013Navigation Straight Bone Probe
- UDI-DI
10889981260040
8 recalled lot codes
AL657979CAL658549CAL658549CRRRAL658641CAL661470CAL671917DAL683456FAL702785F
PC2-400135Navigation, 3.5mm Drill
- UDI-DI
10889981260057
12 recalled lot codes
BK104899ABK104899ARBK104899ARRBK104899ARRRBK104899ARRR4BK106822ACR49020DCR49023DCR49060DCR51550ECR51972DCR56472E
PC2-400140Navigation, 4.0mm Drill
- UDI-DI
10889981260064
13 recalled lot codes
BK104900ABK104900ARBK104900ARRRBK106825ABK107806ABK107806ARRRBK108366ABK108366ARRRCR49822DCR50158DCR51973DCR57547ECR59411E
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- Amount recalled
- 310
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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