Device recall

Z-2793-2026: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix…

FDA device recall · Class II · Alphatec Spine, Inc.

Key facts

Recall number (Z-number) Z-2793-2026
Recall event 98967
Product SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Product code GWF
Recalling firm Alphatec Spine, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K252842
FEI number 2027467

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)