Events

Recall of Device Recall 3 i Implant Innovations, Inc.

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
    25722
  • Event Risk Class
    Class 3
  • Event Number
    Z-0665-03
  • Event Initiated Date
    2003-01-28
  • Event Date Posted
    2003-03-20
  • 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=26364
  • 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
    Sterile endosseous implants may be packaged in mislabeled packaging with the incorrect size.
  • Action
    The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information.

Device

Device Recall 3 i Implant Innovations, Inc.
  • Model / Serial
    For LTX 611 lot number 150102P For LTX 515 lot number 150100P
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile.
  • Product Description
    LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,
  • Manufacturer
    Implant Innovations, Inc.

Manufacturer

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