BEUDAMED
    FDA Enforcement Class II Terminated

    GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

    Recall: Z-0910-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0910-2020
    Event ID
    84334
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Collagen Matrix Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    November 5, 2019
    Classification Date
    January 29, 2020
    Termination Date
    August 3, 2020
    Address
    15 Thornton Rd, N/A, Oakland, NJ, 07436-3115, United States

    Description

    GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

    Reason

    The products may have been packaged with an incorrect Instructions for Use.

    Code Info

    UDI: (01)00366975013279(17)200630; Lot Number EPDMU18H1

    Distribution

    US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IL, MA, MD, MI, MN, NC, NJ, NY, OK, PA, SC, TX, UT, VA, and WA.

    Quantity

    192 total