Events

Recall of Osseocare Pro Console & Set Osseocare Pro

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nobel Biocare Usa Llc.

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
    66664
  • Event Risk Class
    Class 2
  • Event Number
    Z-0273-2014
  • Event Initiated Date
    2013-10-24
  • Event Date Posted
    2013-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122918
  • 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
    Controller, foot, handpiece and cord - Product Code EBW
  • Reason
    The recall was initiated because there is a potential for malfunction of the osseocare pro when used with the oseeocare pro ipad application software release 1.2.0.7.
  • Action
    Bien Air Dental send and Urgent Field Safety Notice dated October 24, 2013, to all affected customers. The letter notified customers of the recall, description of the problem, description of the product (OsseoCare Pro iPad app software release 1.2.0.7), action to be taken by user, an alternative solution, and contact details. The letter was also accompanied by an acknowlegement form. Customers with questions were instructed to call 1-800-433-2436. For questions regarding this recall call 714-282-4800.

Device

Osseocare Pro Console & Set Osseocare Pro
  • Model / Serial
    Model Numbers: 1600870-001, 1700470-001, 1700471-001.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) United States and Internationally to Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
  • Product Description
    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. || Device Name: Osseocare Pro console & Set Osseocare Pro. || Model: 1600870-001, 1700470-001, 1700471-001. || Marketing status: Class I, under K092214. || Device description: Software-based, electronically controlled tabletop device. || In dentistry for dental surgery, endodontics and implantology.
  • Manufacturer
    Nobel Biocare Usa Llc

Manufacturer

Nobel Biocare Usa Llc
  • Manufacturer Address
    Nobel Biocare Usa Llc, 22715/22725 Savi Ranch Pkwy, Yorba Linda CA 92887
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA