BEUDAMED
    FDA Recall 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 · Initiated October 24, 2013

    Recall

    Recall Number
    Z-0273-2014
    Event Number
    66664
    Firm
    Nobel Biocare Usa Llc
    FEI Number
    1000125598
    Product Code
    EBW
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    October 24, 2013
    Posted
    November 13, 2013
    Terminated
    April 10, 2014
    Address
    22715/22725 Savi Ranch Pkwy, Yorba Linda, CA, 92887

    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.

    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.

    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)