The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2237-2016·Announced 2016-07-27

Nobel Biocare Dental Implants Recalled for Incorrect Top Label

Nobel Biocare is recalling 53 Replace Select Tapered dental implants due to incorrect top labels on the packaging. The recall covers units distributed in the US and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 limited to a labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Nobel Biocare USA LLC is recalling 53 units of Replace Select Tapered TiU NP 3.5x11.5mm dental implants (Article No. 36105). The recall was initiated because of an incorrect top label on the implant package. These root-form endosseous implants are intended to be surgically placed in the jawbone to support prosthetic devices such as artificial teeth.

The affected units were distributed worldwide, including 33 units in the United States (specifically in Oregon, Ohio, and New York) and 20 units internationally to Taiwan and Brazil. The recall is classified as Class II by the FDA.

Consumers and healthcare providers who have these specific implants should contact Nobel Biocare USA LLC for instructions on how to return the product or obtain a replacement. The source text does not report any illnesses or injuries associated with this labeling error.

The recalled product

Product
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in…
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard

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)

  • 13030677

Distribution

Distributed in 3 states:

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