Recall Z-0273-2014— Nobel Biocare Usa Llc
Class II · Terminated
Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2013-10-24, terminated 2014-04-10. It names one FDA 510(k) clearance: K092214. 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.. 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
- Nobel Biocare Usa Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-24
- Terminated
- 2014-04-10
- Firm location
- Yorba Linda, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.