Events

Recall of Device Recall The Maestro System 204503, Straight Permucosal Ext, 5mm x 3mm

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
    32335
  • Event Risk Class
    Class 3
  • Event Number
    Z-0925-05
  • Event Initiated Date
    2005-06-03
  • Event Date Posted
    2005-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39754
  • 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
    Accessories, Implant, Dental, Endosseous - Product Code NDP
  • Reason
    The product labeled as a straight permucosal ext, 5mm x 3mm contained a profile abutment for cement.
  • Action
    The domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action.

Device

Device Recall The Maestro System 204503, Straight Permucosal Ext, 5mm x 3mm
  • Model / Serial
    Lot No. C0205048
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    PA, TX, MI, VA and Russia
  • Product Description
    The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
  • 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