BEUDAMED
    FDA Enforcement Class II Ongoing

    Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only)

    Recall: Z-2244-2023 · Reported August 2, 2023

    Enforcement

    Recall Number
    Z-2244-2023
    Event ID
    92213
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Davol, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 2, 2023
    Initiation Date
    April 25, 2023
    Classification Date
    July 27, 2023
    Address
    100 Crossings Blvd, N/A, Warwick, RI, 02886-2850, United States

    Description

    Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only)

    Reason

    Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

    Code Info

    UDI-DI: (01)00801741201967(17)240428(10) Lot Number HUGS2043 HUGT1988

    Distribution

    Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.

    Quantity

    N/A