Nobel Biocare Dental Implant Recall Due to Incorrect Length Labeling
Nobel Biocare is recalling 228 dental implants because the packaging label incorrectly lists the length as 7mm instead of the actual 10mm.
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, and the hazard is a minor labeling error regarding dimensions without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling 228 units of the NobelParallel Conical Connection NP endosseous dental implant (REF 37965, Lot 12129104). The recall was initiated because the top label on the immediate packaging may incorrectly indicate an implant length of 7mm, which is shorter than the actual implant length of 10mm.
The affected products were distributed internationally to Russia only. These implants are intended to be used in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore chewing function.
Consumers and healthcare providers should stop using the affected implants and contact Nobel Biocare USA LLC for further instructions or a replacement.
The recalled product
- Product
- NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements…
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 228
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)
- Lot:12129104
Distribution
Distribution scope not specified by the agency.
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