Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0273-2014·Announced 2013-11-20

Nobel Biocare Recalls Osseocare Pro Dental Devices Due to Malfunction Risk

Nobel Biocare is recalling Osseocare Pro dental consoles because they may malfunction when used with a specific iPad software version.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level involving temporary or medically reversible adverse health consequences, without reported serious injuries or deaths.

Plain-English summary

Nobel Biocare USA LLC is recalling the Osseocare Pro Console & Set Osseocare Pro, including models 1600870-001, 1700470-001, and 1700471-001. The recall was initiated because there is a potential for malfunction of the device when used with the Osseocare Pro iPad application software release 1.2.0.7.

The affected devices are software-based, electronically controlled tabletop devices used in dentistry for dental surgery, endodontics, and implantology. A total of 1,082 units were distributed, with 391 units distributed in the United States. The remaining units were distributed internationally to numerous countries including Austria, Belgium, Brazil, Canada, and others.

Healthcare professionals and consumers should stop using the affected devices with the specified software version. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

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…
Manufacturer: Nobel Biocare Usa Llc
Category: Medical Device — Dental Equipment
Hazard: malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Nobel Biocare Usa Llc

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Same hazard · malfunction