Device recall

Z-0420-2026: TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product…

FDA device recall · Class II · Integra LifeSciences Corp. (NeuroSciences)

Key facts

Recall number (Z-number) Z-0420-2026
Recall event 97677
Product TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Product code PGW
Recalling firm Integra LifeSciences Corp. (NeuroSciences)
Recall class Class II
Status Open, Classified
510(k) numbers K231862
FEI number 3003418325

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)