BEUDAMED
    FDA Enforcement Class II Terminated

    ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

    Recall: Z-1842-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1842-2019
    Event ID
    82909
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 26, 2019
    Initiation Date
    April 19, 2019
    Classification Date
    June 18, 2019
    Termination Date
    February 5, 2021
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

    Reason

    Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

    Code Info

    Lot Code:PBQ797

    Distribution

    Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada

    Quantity

    36 eaches