Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue
Nobel Biocare is recalling 23 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 material issue that may leave a sticky substance on the implant, which is a minor defect without reported injuries or illnesses.
Plain-English summary
Nobel Biocare USA LLC is recalling 23 units of Replace Select Tapered TiU NP 3.5x11.5mm dental implants (Article No. 36105, Batch No. 13011317). The recall was initiated because a material used in the packaging of these implants 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 recall covers units distributed worldwide, including the United States and various international markets.
Consumers and healthcare providers should contact Nobel Biocare USA LLC for instructions on how to return the affected products.
The recalled product
- Product
- Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. 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
- 23
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. 13011317.
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.
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