NobelReplace Dental Implants Recalled Due to Packaging Material Contamination
Nobel Biocare is recalling 5 units of 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. The hazard involves a sticky substance from packaging material, which is a quality defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 5 units of NobelReplace CC PMC RP 4.3x10mm dental implants (Article No. 37291, Batch No. 13011148). The recall is due to a material used in the packaging that 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, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
The FDA has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but the presence of a sticky substance on the implant surface or threads is the identified hazard.
The recalled product
- Product
- NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Affected units
- 5
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. 13011148
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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