BEUDAMED
    FDA Recall Terminated

    Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.

    Recall: Z-1452-2015 · Initiated March 13, 2015

    Recall

    Recall Number
    Z-1452-2015
    Event Number
    70758
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    KGN
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 13, 2015
    Posted
    April 16, 2015
    Terminated
    April 13, 2016
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.

    Reason

    A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).

    Action

    Integra Life Sciences Inc. sent a Recall letter/Recall acknowledgement and return form dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Integra asks customers to review inventory and determine if any of the affected inventory is in possession. The attached Recall Acknowledgement and Return Form should be completed and returned. Customer service will contact the customer upon receipt of the form and provide an RMA number. Questions can be directed to Customer Service at 1-888-301-0203.

    Distribution

    Worldwide Distribution - US Distribution and to the countries of and to the countries of Greece, France, Italy, Spain, Switzerland, South America, Turkey and United Kingdom.

    Quantity

    287 packages ( 179 US 108 OUS )