BEUDAMED
    FDA Enforcement Class II Ongoing

    AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

    Recall: Z-2331-2024 · Reported July 17, 2024

    Enforcement

    Recall Number
    Z-2331-2024
    Event ID
    94804
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2024
    Initiation Date
    June 7, 2024
    Classification Date
    July 10, 2024
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    Description

    AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

    Reason

    Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

    Code Info

    Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.

    Distribution

    Domestic: NY, OH, & DC.

    Quantity

    14 units