Company:Nobel Biocare Usa Llc.
Date of Enforcement Report: 11/20/2013
Class lI:
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. Recall Number Z-0273-2014
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.
RECALLING FIRM/MANUFACTURER
Nobel Biocare Usa Llc, Yorba Linda, CA on 10.246/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1082 (391 US)
DISTRIBUTION
Nationwide and Internationally
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