Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination
Nobel Biocare is recalling 594 units of NobelReplace CC 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 leave a sticky substance on the implant, which is a low-risk contamination issue without reported injuries.
Plain-English summary
Nobel Biocare USA LLC is recalling 594 units of NobelReplace CC NP 3.5x13mm dental implants (Article No. 36702). The affected units are identified by Batch Nos. 13011774, 13011775, 13011776, 13011826, 13011896, and 13012487.
The recall was initiated because a material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads. This issue is classified as an FDA Class II recall.
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 contact Nobel Biocare USA LLC for instructions on how to proceed with the affected units.
The recalled product
- Product
- NobelReplace CC NP 3.5x13mm, Article No. 36702.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 594
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 (6)
- Batch No. 13011774
- 13011775
- 13011776
- 13011826
- 13011896
- 13012487.
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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