Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides co…

Recall date

December 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0977-2025

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.