NobelReplace CC RP Dental Implants Recalled for Packaging Material Contamination
Nobel Biocare is recalling NobelReplace CC RP 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-related contamination (sticky substance) without reporting any illnesses, injuries, or hospitalizations. This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where no harm has been reported.
Plain-English summary
Nobel Biocare USA LLC is recalling 636 units of NobelReplace CC RP 5.0x10mm dental implants (Article No. 36711). The recall involves specific batch numbers: 13011136, 13011367, 13011450, and 13012929.
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 could potentially affect the integrity or handling of the medical device.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Austria, Australia, Belgium, Canada, Germany, and the United Kingdom. Consumers and healthcare providers should check their inventory for the specific batch numbers listed and contact the manufacturer for further instructions on how to proceed with the recall.
The recalled product
- Product
- NobelReplace CC RP 5.0x10mm, Article No. 36711.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 636
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 (4)
- Batch No. 13011136
- 13011367
- 13011450
- 13012929.
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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