Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro c
FDA device recall Z-0273-2014 · posted 2013-11-13 · Terminated
Recall details
- Recalling firm
- Nobel Biocare Usa Llc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- EBW
- Quantity affected
- 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,
- Date initiated
- 2013-10-24
- Date posted
- 2013-11-13
- Date terminated
- 2014-04-10
- Location
- Yorba Linda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHIROPRO L SYSTEM (K092214) | Bien-Air Dental, SA | 2009-12-15 |