Events

Recall of Certain PreFormance

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
    45431
  • Event Risk Class
    Class 3
  • Event Number
    Z-0128-2008
  • Event Initiated Date
    2007-10-08
  • Event Date Posted
    2008-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65458
  • 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 - Product Code NHA
  • Reason
    Incorrect assembly: the product does not allow for the screw to pass through the access hole and engage the implant properly. therefore, the provisional restoration will not be seated on the implant platform.
  • Action
    Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.

Device

Certain PreFormance
  • Model / Serial
    Lot Number: 707303, Expiration Date: 08/31/2012
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, Italy, France, Spain and UK.
  • Product Description
    Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410
  • Manufacturer
    Biomet 3i

Manufacturer

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