BEUDAMED
    FDA Recall Terminated

    Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.

    Recall: Z-1389-2019 · Initiated March 19, 2019

    Recall

    Recall Number
    Z-1389-2019
    Event Number
    82638
    Firm
    Collagen Matrix, Inc.
    FEI Number
    3003300673
    Product Code
    NPL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 19, 2019
    Terminated
    May 12, 2020
    Address
    110 Commerce Dr, Allendale, NJ, 07401-1622

    Description

    Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.

    Reason

    Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

    Action

    Citagenix with the Manufacturer, Collagen Matrix, Inc. issued on, March 19, 2019, the Recall Notice via email advising of the problem, health risk, and action to take: determine the quantity on hand and quarantine. Check distribution records and determine whether any of the affected product was distributed to your customers. Complete the attached Acknowledgement of Receipt Form with the appropriate information and return within 72 hours of receiving this notice to initiate additional recall activities where applicable. Upon receipt of the completed form, Citagenix will provide a prepaid return shipping label with further instructions for returning product that remains in your possession and/or with additional recall activities. If you have any questions after reviewing this notice, please call 1-877-243-6724 between 8:00 am and 5:00 pm EST, Monday through Friday.

    Distribution

    Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.

    Quantity

    45 units -US;170 units OUS