BEUDAMED
    FDA Recall Terminated

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.

    Recall: Z-0458-2014 · Initiated September 25, 2013

    Recall

    Recall Number
    Z-0458-2014
    Event Number
    66627
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    NEW
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    September 25, 2013
    Posted
    December 6, 2013
    Terminated
    May 6, 2016
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.

    Reason

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.

    Action

    Ethicon Inc. sent recall notifications/business reply forms on 9/25/2013 via UPS next day certified mail.

    Distribution

    Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.

    Quantity

    37,164 eaches