CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report

Osseocare Pro console & Set Osseocare Pro recalled by Nobel Biocare Usa

Nobel Biocare Usa is recalling Osseocare Pro console & Set Osseocare Pro, distributed nationwide in the US. The recall was initiated on 24 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: 1600870-001, 1700470-001, 1700471-001.

Quantity recalled1082 (391 US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0273-2014
FDA event ID: 66664
Recalling firm: Nobel Biocare Usa, Yorba Linda, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 Oct 2013
FDA classified: 13 Nov 2013
Reported: 20 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Dental Devices

Timeline

24 Oct 2013	Recall initiated by company
13 Nov 2013	Classified by FDA	+20 days
20 Nov 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it 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 lots are affected?

Model Numbers: 1600870-001, 1700470-001, 1700471-001.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nobel Biocare Usa

All 66

Reported	Class	Recall	Company	Reason	Where
2 Mar 2022Device	CLASS II	NobelReplace Conical Connection RP recalled by Nobel Biocare Usa	Nobel Biocare Usa	Other	Nationwide
10 Jun 2020Device	CLASS II	Healing Abutment Conical Connection RP recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
10 Jun 2020Device	CLASS II	NobelActive Internal NP 3.5x15mm Endosseus dental implant recalled	Nobel Biocare Usa	Other	28 states
13 May 2020Device	CLASS II	Snappy Abutment 5.5 CC RP recalled by Nobel Biocare Usa	Nobel Biocare Usa	Packaging Defects	Nationwide
13 May 2020Device	CLASS II	Temporary Abutment Non-Engaging CC RP pre-manufactured recalled	Nobel Biocare Usa	Packaging Defects	Nationwide

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