The Recall Desk
HighFDA (Devices)·Z-0937-2026·Announced 2025-12-24

[pending] Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF

Pending LLM rewrite. Source: FDA_DEVICE Z-0937-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

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, PC2-4001
Manufacturer
SEASPINE ORTHOPEDICS CORPORATION
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Surgical Technique Guide revisions: D0003926A
  • D0003926B
  • D0003926C
  • D0003926D. REF/UDI-DI/Lot: PC2-400012/10889981260033/MK81527A
  • MK81527ARR
  • MK81527ARRR
  • MK81574AR
  • MK81574AR1
  • MK93487A
  • MK93488ARR
  • MK93489A
  • MK93490A
  • MK93490ARR
  • MK93491AR
  • MK93491AR1
  • MK943488A
  • MK95882A
  • MK95882ARR
  • ML52083B
  • ML53136B

Distribution

Distributed in 24 states:

  • AL
  • AZ
  • CA
  • CO
  • CT
  • FL
  • IL
  • IN
  • MI
  • MO
  • MS
  • NJ
  • NV
  • NY
  • OK
  • OR
  • PA
  • RI
  • SC
  • SD
  • TX
  • UT
  • VA
  • WA

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