Nobel Biocare Recalls Dental Implants Due to Packaging Material Defect
Nobel Biocare is recalling 138 dental implant units 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 (sticky substance) that is a minor labeling/packaging issue without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Nobel Biocare USA LLC is recalling 138 units of NOBELREPLACE Tapered Groovy RP 4.3x8mm dental implants (Article No. 32215). The recall involves Batch Nos. 13011622 and 13013239. These root-form endosseous implants are intended to be surgically placed in the jawbone to support prosthetic devices such as artificial teeth.
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 affected units were distributed nationwide in the United States and internationally to numerous countries including Austria, Australia, Belgium, Canada, Germany, France, the United Kingdom, and others.
Consumers and healthcare providers who have purchased or received these specific dental implants should contact Nobel Biocare USA LLC for instructions on how to return the product or obtain a replacement. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. 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
- 138
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 (2)
- Batch No. 13011622
- 13013239.
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 →Related recalls
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