Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination
Nobel Biocare is recalling 7 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 defect that may leave a sticky substance on the device, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
Nobel Biocare USA LLC is recalling seven units of NOBELREPLACE Tapered Groovy 6.0 6x8mm dental implants (Article No. 32223, Batch No. 13010360). The recall is due to a material in the packaging that may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads.
These root-form endosseous implants are intended to be surgically placed in the bone of the upper or lower jaw arches to support prosthetic devices. The affected units were distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, and various nations in Europe and the Middle East.
Consumers and healthcare providers should stop using the affected implants and contact Nobel Biocare for further instructions.
The recalled product
- Product
- NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. 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 or
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 7
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. 13010360.
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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