Osseocare Pro Console & Set Osseocare Pro — Class II medical device recall Z-0273-2014
Terminated recall by Nobel Biocare Usa Llc, reported 2013-11-20, distributed nationwide. The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the
| Recall number | Z-0273-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nobel Biocare Usa Llc, Yorba Linda, CA, United States |
| Recall initiated | 2013-10-24 |
| Classified | 2013-11-13 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, HR, HU, IE, IN, IT, JP, LT, LU, LV, MX, NL, NO, PH, PL, PT, RO, RU, SE, TR, ZA |
| Reason classes | device malfunction, software |
| Model numbers | 1600870-001, 1700470-001, 1700471-001 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0273-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.