BEUDAMED
    FDA Recall Open, Classified

    CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

    Recall: Z-1717-2025 · Initiated April 11, 2025

    Recall

    Recall Number
    Z-1717-2025
    Event Number
    96694
    Firm
    Integra LifeSciences Corp. (NeuroSciences)
    FEI Number
    3003418325
    Product Code
    HBF
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 11, 2025
    Posted
    May 6, 2025
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650

    Description

    CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

    Reason

    Inadequate weld that can potentially cause the product to disassemble.

    Action

    An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification, dated 4/11/25, was distributed to consignees via mail and email. Consignees are being asked to check their inventory for affected devices and immediately quarantine any product identified. Consignees are asked to complete the provided Acknowledgement Form and return it via email to [email protected] or by fax to 1-609-750-4220; all consignees are to complete and return the form. Integra asks that the recall notification be forwarded to all users of the devices and to customers who received product that was further distributed. Distributors are to collect completed Acknowledgement Forms from their customers and provide them to the firm. Consignees with any questions can contact Customer Service at 1-800-654-2873 or by email at [email protected].

    Distribution

    Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    1,840 units