The Recall Desk
ModerateFDA (Devices)·Z-1437-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

Nobel Biocare is recalling specific dental implants because packaging material may leave a sticky substance on the implant surfaces and threads.

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 defect (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 2 units of NobelReplace CC PMC RP 4.3x8mm dental implants, Article No. 37290, Batch No. 13011562. The recall is due to a material used in the packaging that 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 worldwide, including nationwide in the United States and internationally to numerous countries such as Austria, Australia, Belgium, and Canada. The source text does not specify the number of units distributed beyond the 2 units identified in the recall notice, nor does it report any illnesses or injuries associated with the use of these implants.

Consumers and healthcare providers who have these specific dental implants should contact Nobel Biocare USA LLC for further instructions on how to handle the product. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
2

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. 13011562

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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