FDA-Device2025-12-24Class IIMISBRANDING

SeaSpine NorthStar OCT Navigation surgical instruments recalled for incorrect compatibility guide

FALSE CLAIMSAL AZ CA CO CT FL IL IN MI MO MS NJ NV NY OK OR PA RI SC SD TX UT VA WA Medical devices

What this means

The instruction guide for SeaSpine's NorthStar OCT Navigation surgical instruments incorrectly states that the tools work with both Medtronic Solera and Infinity system toolcards. In fact, they only work with Solera toolcards. Using these instruments with an Infinity system toolcard could result in device malfunction during surgery.

If you have NorthStar OCT Navigation instruments, verify you are using them only with Medtronic Solera toolcards
Do not use these instruments with Medtronic Infinity system toolcards
Contact SeaSpine for an updated instruction guide or confirmation of your system compatibility

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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

Affected count

310

Manufactured in

5770 Armada Dr, Carlsbad, CA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2026

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