BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-1717-2025 · Reported May 14, 2025

    Enforcement

    Recall Number
    Z-1717-2025
    Event ID
    96694
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp. (NeuroSciences)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 14, 2025
    Initiation Date
    April 11, 2025
    Classification Date
    May 6, 2025
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    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.

    Code Info

    Model No. 261230; UDI: 10381780513629; Lot No. Lot Number, 5984530, 7062002, 7062006, 7062013, 7062014, 7255930, 7255931, 7255932, 7255933, 7255934, 7255935, 7255936, 7255937, 7269522, 7269523, 7269524, 7269525, 7282944, 7282945, 7282946, 7282948, 7282949, 7282950, 7282951, 7282952, 7282953, 7293408, 7293409, 7293410, 7293411, 7293412, 7293413, 7293414, 7322892, 7322893, 7322894, 7322895, 7322896, 7322897, 7322898, 7332664, 7332665, 7332666, 7332667, 7332668, 7348744, 7348745, 7348746, 7348747, 7348748, 7371080, 7371081, 7379573, 7379576, 7379577, 7379578.

    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