The Recall Desk
ModerateFDA (Devices)·Z-1416-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

Nobel Biocare is recalling 24 units of Replace Select Tapered TiU NP 3.5x16mm 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 hazard is a packaging defect (sticky substance) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Nobel Biocare USA LLC is recalling 24 units of Replace Select Tapered TiU NP 3.5x16mm dental implants, Article No. 29403, Batch No. 13012695. 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 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. The products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Germany, France, and the United Kingdom.

Consumers and healthcare providers should stop using the affected implants and contact Nobel Biocare for further instructions. 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.

The recalled product

Product
Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. 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 o
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
24

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. 13012695.

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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