Recall of MicroMiniplant

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
    37865
  • Event Risk Class
    Class 3
  • Event Number
    Z-0811-2007
  • Event Initiated Date
    2007-04-25
  • Event Date Posted
    2007-05-16
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2008-11-18
  • Event Source
    USFDA
  • Event Source URL
  • 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 component - Product Code DZE
  • Reason
    The straight healing abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
  • Action
    Each consignee was notified on 4/25/2007 by telephone using a prepared script. A follow letter was sent by fax. Each consignee was instructed to check their respective inventory for the affected product and to return a response card and any affected product to the firm.

Device

  • Model / Serial
    lot Numbers: 593025-5, 593027-5, 598408-5, 593028-5, 599866-5 and 593029-5.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed worldwide, including USA, Spain and the Netherlands.
  • Product Description
    Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.
  • Manufacturer

Manufacturer

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