Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue
Nobel Biocare is recalling specific NobelReplace dental implants because packaging material may leave a sticky substance on the implant surfaces.
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 a packaging material issue causing a sticky substance rather than a direct health threat like infection or injury. No illnesses or injuries are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 448 units of NobelReplace CC RP 4.3x13mm dental implants (Article No. 36708). The recall involves specific batch numbers: 13011199, 13011200, 13012501, and 13012514.
The recall was initiated because a material used in the packaging of these dental implants may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads. This issue affects the physical condition of the device rather than posing an immediate biological hazard.
The affected products were distributed nationwide in the United States and internationally to numerous countries including Austria, Australia, Belgium, Bulgaria, Canada, and others. Healthcare professionals and patients who have received or purchased these specific implants should contact Nobel Biocare for further instructions on how to proceed.
The recalled product
- Product
- NobelReplace CC RP 4.3x13mm, Article No. 36708.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Affected units
- 448
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 (4)
- Batch No. 13011199
- 13011200
- 13012501
- 13012514.
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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