Events

Recall of standard Abutment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Implant Innovations, 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
    30203
  • Event Risk Class
    Class 2
  • Event Number
    Z-0029-05
  • Event Initiated Date
    2004-10-04
  • Event Date Posted
    2004-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35393
  • 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
    The nylon bag holding the product was not completely sealed before sterilization. patients could be infected if the abutment is implanted.
  • Action
    Begining on October 4, 2004 each direct account was contacted by email, faxed letter and telephone. They were informed of the recall and instructed to contact their customers if the product had been sold.

Device

standard Abutment
  • Model / Serial
    Product Code: THA54 Lot No. 249229
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
  • Product Description
    EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
  • Manufacturer
    Implant Innovations, Inc.

Manufacturer

Implant Innovations, Inc.
  • Manufacturer Address
    Implant Innovations, Inc., 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Source
    USFDA