The Recall Desk
ModerateFDA (Devices)·Z-1435-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue

Nobel Biocare is recalling 216 units of NobelReplace CC PMC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.

What this means for you

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, but the source text describes a packaging material issue (sticky substance) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Nobel Biocare USA LLC is recalling 216 units of NobelReplace CC PMC NP 3.5x11.5mm dental implants (Article No. 37287, Batch No. 13011140). The recall was initiated because a material used in the packaging may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads.

The affected products were distributed nationwide in the United States and internationally to numerous countries, including Austria, Australia, Belgium, Bulgaria, Canada, and others. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers who have purchased or received these specific dental implants should stop using them and contact Nobel Biocare USA LLC for further instructions on how to return or dispose of the product.

The recalled product

Product
NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
216

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 (1)

  • Batch No. 13011140.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 recalled by Nobel Biocare Usa Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 27 products in this recall →

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Same manufacturer · Nobel Biocare Usa Llc

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