BEUDAMED
    FDA Enforcement Class II Terminated

    Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

    Recall: Z-1300-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1300-2018
    Event ID
    79494
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 11, 2018
    Initiation Date
    December 15, 2017
    Classification Date
    April 3, 2018
    Termination Date
    April 13, 2020
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

    Reason

    Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.

    Code Info

    Lot numbers: 129385 129386 133824 133825 133826 133827 133828 133829 133830 133831 134609 134610 134611 134612 134613 134614 135476 135477 135478 145664 145665 145666 145667 145668 145669 145670 145671 147555 152905 152906 152908 153880 153881 153882 153883 153884 153885 153886 153888 153889 154956 154957 HVKBHH HVKBHJ

    Distribution

    International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.

    Quantity

    1972