BEUDAMED
    FDA Enforcement Class II Terminated

    PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.

    Recall: Z-0367-2016 · Reported December 9, 2015

    Enforcement

    Recall Number
    Z-0367-2016
    Event ID
    72591
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merz North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2015
    Initiation Date
    October 26, 2015
    Classification Date
    December 3, 2015
    Termination Date
    May 8, 2017
    Address
    6501 Six Forks Rd, Raleigh, NC, 27615-6515, United States

    Description

    PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.

    Reason

    The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

    Code Info

    Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932

    Distribution

    Distributed US (nationwide) including the Virgin Islands and South Africa.

    Quantity

    7,715 units