Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 20, 2013
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nobel Biocare Usa Llc recalled Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-00… - a moderate-severity action.
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-00… was recalled by Nobel Biocare Usa Llc in November 20, 2013. Reason: The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the…. Check the official notice for the remedy. Verify recall #Z-0273-2014 with the FDA Devices before acting.
The recall
Nobel Biocare Usa Llc issued this moderate-severity FDA Devices recall-The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the….
- Moderate
- severity level
- Class II
- classification
- November 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0273-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0273-2014) was formally reported on November 20, 2013, with the manufacturer initiating the action on October 24, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Nobel Biocare Usa Llc is listed as the recalling firm, operating out of Yorba Linda, CA. Federal records list the affected scope as 1082 (391 US).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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, Jap…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1082 (391 US)
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0273-2014 |
| Date reported | November 20, 2013 |
| Date initiated | October 24, 2013 |
| Recalling firm | Nobel Biocare Usa Llc |
| Firm location | Yorba Linda, CA |
| Affected scope | 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, Lithuani… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0273-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nobel Biocare Usa Llc. Units affected: 1082 (391 US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0273-2014.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0273-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 20, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.