BEUDAMED
    FDA Recall Terminated

    Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 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-0924-2013 · Initiated July 5, 2011

    Recall

    Recall Number
    Z-0924-2013
    Event Number
    64477
    Firm
    Keystone Dental Inc
    FEI Number
    3005990499
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 5, 2011
    Posted
    March 8, 2013
    Terminated
    March 11, 2013
    Address
    144 Middlesex Tpke, Burlington, MA, 01803-4403

    Description

    Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 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 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment

    Action

    Keystone issued Market Withdrawal notice via fax on July 5, 2011, to affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and return the fax-back form to facilitate whether they hae any affected product and indicate whether they would like to receive a replacement of a full refund. Customers ewre asked to contact Keyston'es Customer Relations Department to coordinate shipment of the returned product. For questions regarding this recall call 781-328-3390.

    Distribution

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

    Quantity

    22 units