Device recall

Z-0937-2026: Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments…

FDA device recall · Class II · SEASPINE ORTHOPEDICS CORPORATION

Key facts

Recall number (Z-number) Z-0937-2026
Recall event 97973
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…
Product code OLO
Recalling firm SEASPINE ORTHOPEDICS CORPORATION
Recall class Class II
Status Open, Classified
510(k) numbers K172517
FEI number 3012120772

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)