BEUDAMED
    FDA Enforcement Class II Terminated

    Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.

    Recall: Z-0923-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0923-2013
    Event ID
    64477
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    FAX
    Report Date
    March 20, 2013
    Initiation Date
    July 5, 2011
    Classification Date
    March 8, 2013
    Termination Date
    March 11, 2013
    Address
    144 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States

    Description

    Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.

    Reason

    Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,

    Code Info

    Lot Number: 2376 Exp Date: 09/2013

    Distribution

    Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.

    Quantity

    35 units