BEUDAMED
    FDA Recall 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 · Initiated October 26, 2015

    Recall

    Recall Number
    Z-0367-2016
    Event Number
    72591
    Firm
    Merz North America, Inc.
    FEI Number
    1012187
    Product Code
    MIX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 26, 2015
    Posted
    December 3, 2015
    Terminated
    May 8, 2017
    Address
    6501 Six Forks Rd, Raleigh, NC, 27615-6515

    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.

    Action

    Letters were issued 11/4/2015 to consignees. The letter informs the consignees that they can continue to safely use the affected products by referring to the USE BEFORE date. They letter does not require for any product to be returned. Also, there is no sub-recall required as the product was not distributed to distributors or wholesalers.

    Distribution

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

    Quantity

    7,715 units