BEUDAMED
    FDA Enforcement Class II Terminated

    Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

    Recall: Z-0839-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0839-2015
    Event ID
    69835
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instradent USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2014
    Initiation Date
    August 11, 2014
    Classification Date
    December 22, 2014
    Termination Date
    February 6, 2015
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008, United States

    Description

    Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function

    Reason

    Product not approved for use in the US

    Code Info

    Lot Number: 800115427

    Distribution

    Nationwide Distribution including AZ, CA, NY, and MA.

    Quantity

    13 units