NobelReplace Dental Implants Recalled for Packaging Material Contamination
Nobel Biocare is recalling 23 units of NobelReplace CC PMC NP 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 material defect that may affect the physical surface of the implant. No injuries or illnesses are reported, and the issue is a voluntary precautionary recall regarding a potential physical defect rather than a high-risk pathogen or structural failure.
Plain-English summary
Nobel Biocare USA LLC is recalling 23 units of NobelReplace CC PMC NP 3.5x13mm dental implants, Article No. 37288, Batch No. 13010297. 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 products were distributed nationwide in the United States and internationally to 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.
Healthcare providers and patients should stop using the affected implants and contact Nobel Biocare USA LLC for further instructions regarding the recall.
The recalled product
- Product
- NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Affected units
- 23
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. 13010297
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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