Reported Nov 20, 2013 · Terminated
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro…
Nobel Biocare USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nobel Biocare Usa Llc · 22715/22725 Savi Ranch Pkwy · Yorba Linda, CA · 92887
Is this the product you have?
Osseocare Pro Console & Set Osseocare ProModel 1600870-0011700470-001and 1700471-001
- Device NameOsseocare Pro console & Set Osseocare Pro
- Model
1600870-0011700470-0011700471-001
- Marketing statusClass I, under K092214
- Device descriptionSoftware-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology
- Lot codes and dates
- Model Numbers
1600870-0011700470-0011700471-001
- Model Numbers
- Amount recalled
- 1082 (391 US)
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Nobel Biocare USA LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.