Events

Recall of Neodent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instradent USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69835
  • Event Risk Class
    Class 2
  • Event Number
    Z-0839-2015
  • Event Initiated Date
    2014-08-11
  • Event Date Posted
    2014-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131607
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, endosseous, root-form - Product Code DZE
  • Reason
    Product not approved for use in the us.
  • Action
    Neodent iniated the recall by telephone and follow-up Recall Notification letter with Confirmation form onAugust 14, 2014, requesting the return of unused product. Customers with questions were instructed to call 978-809-6275. For questions regarding this recall call 855-412-8883, ext 6366.

Device

Neodent
  • Model / Serial
    Lot Number: 800115427
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AZ, CA, NY, and MA.
  • Product 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
  • Manufacturer
    Instradent USA, Inc.

Manufacturer

Instradent USA, Inc.
  • Manufacturer Address
    Instradent USA, Inc., 60 Minuteman Rd, Andover MA 01810-1008
  • Manufacturer Parent Company (2017)
    Straumann Holding AG
  • Source
    USFDA