Nobel Biocare Usa Llc: Medical Device Recall in 2013 - (Recall #: Z-0273-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: October 24, 2013

Date Posted: November 20, 2013

Recall Number: Z-0273-2014

Event ID: 66664

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.

Status: Terminated

Product Quantity: 1082 (391 US)

Code Information:

Model Numbers: 1600870-001, 1700470-001, 1700471-001.

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.

Voluntary or Mandated:

Voluntary: Firm initiated