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.
FDA Recall Z-0273-2014 · Posted 2013-11-13
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Recalling FirmNobel Biocare Usa Llc
Recall StatusTerminated
Product CodeEBW
Date Initiated2013-10-24
Date Terminated2014-04-10
Product Quantity1082 (391 US)
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.
Firm 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.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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