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Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides
Recalled January 29, 2025 · FDA recall Z-0979-2025 · Integra LifeSciences
Hazard
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. · FDA Class II
Units
46 units
Sold at
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.
Description
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
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.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →