BEUDAMED
    FDA Enforcement Class II Terminated

    Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.

    Recall: Z-1338-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1338-2019
    Event ID
    82653
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2019
    Initiation Date
    March 31, 2019
    Classification Date
    May 15, 2019
    Termination Date
    May 7, 2020
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    Description

    Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.

    Reason

    Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months

    Code Info

    Lot Code: 2991332

    Distribution

    Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil

    Quantity

    274 units