Z-0273-2014Class II

Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name...

Name: Z-0273-2014 Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name...
Creator: Nobel Biocare Usa Llc
Published: 2013-10-24
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2013-10-24 / Terminated / root cause: software

FDA source

Nobel Biocare Usa Llc began a recall of Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model... on 2013-10-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0273-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-24
Posted: 2013-11-13
Terminated: 2014-04-10
Recalling firm: Nobel Biocare USA LLC
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.
Product code: EBW Controller, Foot, Handpiece And Cord
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Model Numbers: 1600870-001, 1700470-001, 1700471-001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0273-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0273-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13

Product code EBW

K092214Class IChiropro L SystemBien-Air Dental, SA / cleared 2009-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)