BEUDAMED
    FDA Recall Terminated

    DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45

    Recall: Z-0668-2022 · Initiated December 13, 2021

    Recall

    Recall Number
    Z-0668-2022
    Event Number
    89495
    Firm
    Collagen Matrix, Inc.
    FEI Number
    3003300673
    Product Code
    GXQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 13, 2021
    Posted
    February 24, 2022
    Terminated
    September 18, 2024
    Address
    110 Commerce Dr, Allendale, NJ, 07401-1622

    Description

    DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45

    Reason

    Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

    Action

    On Monday, December 6, 2021, Collagen Matrix Inc began informing the distributors (initial consignees) to place the lot in question on ship hold. On Monday, December 13, 2021, Collagen Matrix began issuing Urgent Medical Device Recall Notice letter to distributors via email. Letter states reason for recall, health risk and action to take: Check your inventory and that of your sub-distributors if applicable to determine if any of the affected product remains in stock and segregate all affected units from your inventory for return. Complete the Certificate of Acknowledgement form with the appropriate information and return within 5 days of receiving this notice. The completed form can be emailed to [email protected] or returned by mail to: Product Recall Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 Upon receipt of the completed form, Collagen Matrix will ship replacement product and a prepaid return shipping label will be provided with further instructions for returning product that remains in your possession return the concerned products. If you have any questions after reviewing this notice, please call 201-405-1477, ext. 303 between 8:00am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail

    Distribution

    DuraMatrix-Onlay distributed US Nationwide in the states of FL, IN, Puerto Rico, and the countries of Canada, Chile, and Colombia. RESODURA matrix onlay distributed in Germany.

    Quantity

    68 units