BEUDAMED
    FDA Enforcement Class II Ongoing

    CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

    Recall: Z-2363-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2363-2023
    Event ID
    92749
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2023
    Initiation Date
    July 12, 2023
    Classification Date
    August 9, 2023
    Address
    4340 Swinnea Rd, N/A, Memphis, TN, 38118-6603, United States

    Description

    CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

    Reason

    Incorrect Laser Marking - Solera Awl Tip Tap

    Code Info

    SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside the SOLERA TAPS Kit (REF 9735465, GTIN 00763000564087), Lot Numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200

    Distribution

    US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.

    Quantity

    13 devices