Nobel Biocare Recalls Dental Implants Due to Packaging Material Defect
Nobel Biocare is recalling 357 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 source text describes a packaging material defect (sticky substance) without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 357 units of Replace Select Tapered TiU WP 5.0x10mm dental implants (Article No. 29423). The affected units are identified by Batch Nos. 13012523, 13012525, and 13012987. These root-form endosseous implants are intended to be surgically placed in the jawbone to support prosthetic devices.
The recall was initiated because a material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Austria, Australia, Belgium, Canada, Germany, and the United Kingdom. Consumers and healthcare providers should contact Nobel Biocare for further instructions regarding the affected units.
The recalled product
- Product
- Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. 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
- Affected units
- 357
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 (3)
- Batch No. 13012523
- 13012525
- 13012987.
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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