Device recall

Z-0324-2026: SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP)…

FDA device recall · Class II · Surgical Theater Inc

Key facts

Recall number (Z-number) Z-0324-2026
Recall event 97715
Product SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Product code SFB
Recalling firm Surgical Theater Inc
Recall class Class II
Status Completed
510(k) numbers K243623
FEI number 3010197287

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)