BEUDAMED
    FDA Enforcement Class II Completed

    ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease

    Recall: Z-1698-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1698-2024
    Event ID
    94279
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Advanced Research Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 8, 2024
    Initiation Date
    March 14, 2023
    Classification Date
    April 29, 2024
    Address
    1515 Highway 13 E, Burnsville, MN, 55337-2917, United States

    Description

    ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease

    Reason

    Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.

    Code Info

    UDI/DI 00850014575311, Lot Numbers: 87458, BB059AA, BB140AA, BB140AB, BB307AA, BB350AA, BC061AA, BC130AA, BC130AA-2, BC274AA, BD083AA, BD083AB, BD083AC

    Distribution

    US Nationwide distribution in the state of Minnesota.

    Quantity

    1150 units