BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

    Recall: Z-2357-2024 · Reported July 24, 2024

    Enforcement

    Recall Number
    Z-2357-2024
    Event ID
    94872
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SEASPINE ORTHOPEDICS CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2024
    Initiation Date
    June 4, 2024
    Classification Date
    July 15, 2024
    Address
    5770 Armada Dr, Carlsbad, CA, 92008-4608, United States

    Description

    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

    Reason

    Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

    Code Info

    Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H

    Distribution

    The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona

    Quantity

    100 units