BEUDAMED
    FDA Recall 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 · Initiated March 31, 2019

    Recall

    Recall Number
    Z-1338-2019
    Event Number
    82653
    Firm
    Integra Limited
    FEI Number
    3001700044
    Product Code
    KGN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 31, 2019
    Terminated
    May 7, 2020
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    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

    Action

    Integra Lifesciences notified consignees (Hospitals, Distributors and Sales reps) by letter delivered by courier service, facsimile or email on April 1st, 2019. Letter identifies problems, health risk and action to take: review inventory, immediately stop use and return product and complete the Acknowledgment form. Questions Contact Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM 8:00 PM EST or [email protected].

    Distribution

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

    Quantity

    274 units