Events

Recall of Biohorizons 3.0mm Overdenture Implant System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioHorizons Implant Systems 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
    37893
  • Event Risk Class
    Class 3
  • Event Number
    Z-0801-2007
  • Event Initiated Date
    2007-04-18
  • Event Date Posted
    2007-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52102
  • 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 system - Product Code DZE
  • Reason
    Dental implant system is missing ball attachment system.
  • Action
    Letters explaining the problem and MBAS systems were sent via United Parcel Service (UPS) 3rd day package delivery to the consignees (both domestic and abroad) on 04/18/2007.

Device

Biohorizons 3.0mm Overdenture Implant System
  • Model / Serial
    Lot No. S0207053
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution ---- USA and country of Italy
  • Product Description
    Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
  • Manufacturer
    BioHorizons Implant Systems Inc

Manufacturer

BioHorizons Implant Systems Inc
  • Manufacturer Address
    BioHorizons Implant Systems Inc, One Perimeter Park South, Suite 230, South, Birmingham AL 35243
  • Source
    USFDA