Events

Recall of Device Recall 3i

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
    28092
  • Event Risk Class
    Class 2
  • Event Number
    Z-0387-04
  • Event Initiated Date
    2003-12-02
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31194
  • 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
    Drill, Bone, Powered - Product Code DZI
  • Reason
    The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
  • Action
    The firm notified international distributors on 12/2/2003 via e-mail and also a recall notification letter was faxed to them on 12/2/2003. They were instructed to subrecall to the health professional level. Also on 12/2/2003 all domestic accounts (health practioners) were telephoned and then faxed a recall notification letter. Each account was instructed to check their inventory, respond back by fax and to return recalled product to Implant Innovations Inc.

Device

Device Recall 3i
  • Model / Serial
    221393
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.
  • Product Description
    Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT423 LOT 4.25 mm (D) X 13.0 mm (L) Disposable Twist Drill STERILE
  • Manufacturer
    Implant Innovations, Inc.

Manufacturer

Implant Innovations, Inc.
  • Manufacturer Address
    Implant Innovations, Inc., 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Source
    USFDA