The Recall Desk
ModerateFDA (Devices)·Z-1420-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Contamination

Nobel Biocare is recalling 74 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, and the hazard involves a packaging defect that may leave a sticky substance on the device, which is a low-risk contamination issue without reported injuries.

Plain-English summary

Nobel Biocare USA LLC is recalling 74 units of NOBELREPLACE Tapered Groovy RP 4.3x10mm dental implants (Article No. 32216, Batch No. 13012851). 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 implants were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, and various nations in Europe and the Middle East. These implants are intended to be surgically placed in the jawbone to support prosthetic devices like artificial teeth.

Consumers and healthcare providers who have purchased or received these specific implants should contact Nobel Biocare USA LLC for further instructions on how to handle the product.

The recalled product

Product
NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
74

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. 13012851.

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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