The Recall Desk
ModerateFDA (Devices)·Z-1434-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

Nobel Biocare is recalling 106 units of NobelReplace CC RP 5.0x13mm 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a packaging contamination issue (sticky substance) rather than a direct biological or structural failure, fitting the Moderate severity criteria for low-risk contamination or precautionary measures.

Plain-English summary

Nobel Biocare USA LLC is recalling 106 units of NobelReplace CC RP 5.0x13mm dental implants (Article No. 36713). The recall involves Batch Nos. 13010964 and 13011549. The product was distributed nationwide in the US and internationally to numerous countries including Austria, Australia, Belgium, and Canada.

The recall was initiated because a material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads. This contamination could potentially affect the integrity or handling of the medical device.

Healthcare providers and patients who have received or are considering these specific implants should contact Nobel Biocare USA LLC for further instructions on how to proceed. The company is responsible for managing the recall and providing guidance on the affected units.

The recalled product

Product
NobelReplace CC RP 5.0x13mm, Article No. 36713.
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
106

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 (2)

  • Batch No. 13010964
  • 13011549.

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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