FDA recall Z-0979-2025

Integra LifeSciences Corp. · Class II · device

Product

CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. 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

Status
Ongoing
Initiation date
2024-12-16
Report date
2025-01-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0979-2025