Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination
Nobel Biocare is recalling 53 units of NobelReplace CC PMC RP 5.0x10mm 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, but the source text describes a packaging contamination issue (sticky substance) without reporting any injuries, illnesses, or specific functional failures, aligning with the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Nobel Biocare USA LLC is recalling 53 units of NobelReplace CC PMC RP 5.0x10mm dental implants (Article No. 37296). The recall involves Batch Nos. 13010961 and 13013308. The product was 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 Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
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 is an FDA Class II recall.
Consumers and healthcare providers should stop using the affected implants and contact Nobel Biocare USA LLC for further instructions or a return.
The recalled product
- Product
- NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 53
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 (2)
- Batch No. 13010961
- 13013308
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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