BEUDAMED
    FDA Enforcement Class II Terminated

    DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    Recall: Z-2067-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2067-2020
    Event ID
    85485
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2020
    Initiation Date
    February 13, 2020
    Classification Date
    May 21, 2020
    Termination Date
    February 26, 2021
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    Reason

    Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

    Code Info

    Lot number: AAD-1801-16 and UDI: (01)00884450374399(17)221231(10)AAD-1801-16; Lot number: AAD-1801-17 and UDI: (01)00884450374399(17)221231(10)AAD-1801-17; Lot number: AAD-1803-01 and UDI: (01)00884450374399(17)230331(10)AAD-1803-01; Lot number: AAD-1804-05 and UDI: (01)00884450374399(17)230430(10)AAD-1804-05; Lot number: AAD-1901-07 and UDI: (01)00884450374399(17)231231(10)AAD-1901-07; Lot number: AAD-1904-04 and UDI: (01)00884450374399(17)240430(10)AAD-1904-04.

    Distribution

    Worldwide distribution: US Nationwide distribution including in the states of (TX, UT, PA, KY, TX, AR, CA, and PA) which included one (1) government/military consignee in KY; and the countries of (Germany, Switzerland, and New Zealand).

    Quantity

    228