BEUDAMED
    FDA Enforcement Class II Terminated

    RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125

    Recall: Z-0669-2022 · Reported March 2, 2022

    Enforcement

    Recall Number
    Z-0669-2022
    Event ID
    89495
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Collagen Matrix, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2022
    Initiation Date
    December 13, 2021
    Classification Date
    February 24, 2022
    Termination Date
    September 18, 2024
    Address
    110 Commerce Dr, Allendale, NJ, 07401-1622, United States

    Description

    RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125

    Reason

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

    Code Info

    Lot Number 2107292022 Exp. Date: 7/31/2024 UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)

    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

    10 units