Events

Recall of Device Recall XiVE Endosseous dental Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dentsply Friadent Ceramed.

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
    36844
  • Event Risk Class
    Class 2
  • Event Number
    Z-0232-2007
  • Event Initiated Date
    2006-11-17
  • Event Date Posted
    2006-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49446
  • 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
    Dental Implant - Product Code DZE
  • Reason
    Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
  • Action
    Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product.

Device

Device Recall XiVE Endosseous dental Implant
  • Model / Serial
    Model # 26-0125
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide-USA and one Canadian consignee.
  • Product Description
    XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125, Friadent GmbH. (dental implant)
  • Manufacturer
    Dentsply Friadent Ceramed

Manufacturer

Dentsply Friadent Ceramed
  • Manufacturer Address
    Dentsply Friadent Ceramed, 12860 W Cedar Dr Ste 101, Lakewood CO 80228-1965
  • Source
    USFDA