BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0273-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0273-2014
    Event ID
    66664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nobel Biocare Usa Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    October 24, 2013
    Classification Date
    November 13, 2013
    Termination Date
    April 10, 2014
    Address
    22715/22725 Savi Ranch Pkwy, Yorba Linda, CA, 92887, United States

    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.

    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.

    Code Info

    Model Numbers: 1600870-001, 1700470-001, 1700471-001.

    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.

    Quantity

    1082 (391 US)