Events

Recall of Device Recall OsseoFix Drill

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Implant Innovations, 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
    26370
  • Event Risk Class
    Class 2
  • Event Number
    Z-0923-03
  • Event Initiated Date
    2003-05-09
  • Event Date Posted
    2003-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27573
  • 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
    Implant, Endosseous, Root-Form - Product Code DZE
  • Reason
    Some 8mm osseofix drills included in the kit may be incorrectly laser marked as 4mm osseofix drills.
  • Action
    The firm faxed and e-mailed a recall communication to international accounts on 5/9/2003 and mailed recall letters to domestic accounts on 5/12/2003. The firms were requested to examine their stock and return product as well as to notify any subaccounts of the recall and recover and return their products. Letters to specific consignees only listed the recalled lot numbers that were shipped to that consignee. A response form was included and was to be faxed back to the recalling firm.

Device

Device Recall OsseoFix Drill
  • Model / Serial
    lot numbers 126509, 183758, 186315, 188528, 187918, 188867, 190033, 191429, 196769.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
  • Product Description
    Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.
  • Manufacturer
    Implant Innovations, Inc.

Manufacturer

Implant Innovations, Inc.
  • Manufacturer Address
    Implant Innovations, Inc., 4555 Riverside Dr, Palm Beach Gardens FL 33410
  • Source
    USFDA