BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-0977-2025 · Initiated December 16, 2024

    Recall

    Recall Number
    Z-0977-2025
    Event Number
    95951
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    JXG
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    December 16, 2024
    Posted
    January 17, 2025
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650

    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

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

    Action

    Integra LifeSciences notified consignees on about 12/16/2024 via letter. Consignees were instructed to review and understand the information provided in the letter, complete and return the provided Customer Acknowledgement Form, remove any affected units from service and quarantine them, arrange for return of affected units, and forward the notification to anyone who utilizes the affected units. Distributors were instructed to follow the same directions but also requested to notify any customers if product was further distributed, and return affected 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.

    Quantity

    132 units