Device recall

Z-0728-2023: VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

FDA device recall · Class II · Icotec Ag

Key facts

Recall number (Z-number) Z-0728-2023
Recall event 91174
Product VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
Product code NKB
Recalling firm Icotec Ag
Recall class Class II
Status Terminated
Termination date Sep 10, 2026
510(k) numbers K190545, K193423, K200596
FEI number 3006493760

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

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