# FDA recall Z-0977-2025

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2024-12-16.

## Product

CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810    Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

## Reason for recall

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

## Distribution

US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.

## Key facts

- **Recall number:** Z-0977-2025
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-16
- **Report date:** 2025-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0977-2025

## Citation

> AI Analytics. FDA recall Z-0977-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0977-2025. Source: US FDA. Licensed CC0.

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