Events

Recall of Device Recall Disposable Twist Drills

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
    37994
  • Event Risk Class
    Class 2
  • Event Number
    Z-0959-2007
  • Event Initiated Date
    2007-05-14
  • Event Date Posted
    2007-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52643
  • 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
    Drills - Product Code DZE
  • Reason
    The depth indicator laser line markings on the drills are too faint for clinicians to read during use.
  • Action
    Each domestic consignee was contacted on 5/14/07 by phone using a prepared script. A follow up letter was then faxed to each consignee. International consignees were contacted by email followed by a faxed letter. Each consignee was instructed to examine their inventory for the recalled product. They were requested to complete and fax back a response form to Biomet and to return any affected product.

Device

Device Recall Disposable Twist Drills
  • Model / Serial
    Lot Numbers: 635699 and 652460
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    World Wide: USA states including: NY, MA, MD, NJ, IL, DE, RI, CA, MI, VA, KS and fL. Internationally to Brazil, Germany, France, Great Briton Japan, Greece and Italy.
  • Product Description
    Biomet 3 i, Disposable Twist Drills, Model Number DT2715.
  • Manufacturer
    Biomet 3i

Manufacturer

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