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U.S. Department of Health and Human Services

Class 2 Device Recall Osseocare Pro Console & Set Osseocare Pro

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  Class 2 Device Recall Osseocare Pro Console & Set Osseocare Pro see related information
Date Initiated by Firm October 24, 2013
Date Posted November 13, 2013
Recall Status1 Terminated 3 on April 10, 2014
Recall Number Z-0273-2014
Recall Event ID 66664
510(K)Number K092214  
Product Classification Controller, foot, handpiece and cord - Product Code EBW
Product 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.
Code Information Model Numbers: 1600870-001, 1700470-001, 1700471-001.
Recalling Firm/
Manufacturer		 Nobel Biocare Usa Llc
22715/22725 Savi Ranch Pkwy
Yorba Linda CA 92887
For Additional Information Contact
714-282-4800
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
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.
Quantity in Commerce 1082 (391 US)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EBW and Original Applicant = BIEN-AIR DENTAL, SA
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