NobelReplace Dental Implants Recalled for Packaging Material Contamination
Nobel Biocare is recalling NobelReplace 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 sticky substance from packaging material without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 1,077 units of NobelReplace CC RP 4.3x10mm dental implants (Article No. 36705). The recall affects specific batches distributed nationwide in the US and internationally to numerous countries including Austria, Australia, Belgium, and Canada.
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 contamination is a result of the packaging material interacting with the product.
Healthcare providers and consumers who have these specific dental implants should contact Nobel Biocare USA LLC for further instructions on how to proceed. The affected batch numbers are 13011154, 13011155, 13011202, 13011380, 13011619, 13011621, 13012148, 13012150, and 13012520.
The recalled product
- Product
- NobelReplace CC RP 4.3x10mm, Article No. 36705.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Affected units
- 1,077
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 (9)
- Batch No. 13011154
- 13011155
- 13011202
- 13011380
- 13011619
- 13011621
- 13012148
- 13012150
- 13012520.
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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