BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0978-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-0978-2025
    Event ID
    95951
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2025
    Initiation Date
    December 16, 2024
    Classification Date
    January 17, 2025
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

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

    Reason

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

    Code Info

    UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.

    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.

    Quantity

    170 units