BEUDAMED
    FDA Enforcement Class II Ongoing

    Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607

    Recall: Z-1614-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1614-2023
    Event ID
    92180
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2023
    Initiation Date
    April 11, 2023
    Classification Date
    May 19, 2023
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    Description

    Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607

    Reason

    Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.

    Code Info

    UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710

    Distribution

    PA Foreign: Australia, Belgium

    Quantity

    337 units