Device recall

Z-0978-2025: CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number…

FDA device recall · Class II · Integra LifeSciences Corp.

Key facts

Recall number (Z-number) Z-0978-2025
Recall event 95951
Product CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Product code JXG
Recalling firm Integra LifeSciences Corp.
Recall class Class II
Status Open, Classified
510(k) numbers K223330
FEI number 3003418325

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)