CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantabl...
FDA Recall #Z-0977-2025 — Class II — December 16, 2024
Product Description
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.
Recalling Firm
Integra LifeSciences Corp. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
132 units
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.
Code Information
UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated