Events

Recall of EP Healing abutment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet 3i.

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
    36616
  • Event Risk Class
    Class 2
  • Event Number
    Z-0922-2007
  • Event Initiated Date
    2006-10-16
  • Event Date Posted
    2007-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49009
  • 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
    Healing abutment - Product Code DZE
  • Reason
    Package integrity; sterility compromised-incomplete seals on the nylon bags in which the product is packed.
  • Action
    Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.

Device

EP Healing abutment
  • Model / Serial
    Lot Number: 560988
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide.
  • Product Description
    EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
  • Manufacturer
    Biomet 3i

Manufacturer

Biomet 3i
  • Manufacturer Address
    Biomet 3i, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Source
    USFDA