BEUDAMED
    FDA Enforcement Class II Terminated

    Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

    Recall: Z-1694-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1694-2018
    Event ID
    79738
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Straumann Manufacturing, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    March 23, 2018
    Classification Date
    May 4, 2018
    Termination Date
    May 2, 2019
    Address
    60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States

    Description

    Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

    Reason

    A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.

    Code Info

    Lot LT830, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019 Lot NP340, Syringe Blister Lot NA438A, Exp 3/31/2019

    Distribution

    Distributed US Nationwide and Puerto Rico.

    Quantity

    3046