BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures. Component: No

    Recall: Z-1008-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-1008-2025
    Event ID
    96099
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integrity Implants Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2025
    Initiation Date
    December 20, 2024
    Classification Date
    January 22, 2025
    Address
    354 Hiatt Dr, Palm Beach Gardens, FL, 33418-7236, United States

    Description

    Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures. Component: No

    Reason

    Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).

    Code Info

    Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045

    Distribution

    U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.

    Quantity

    9