Nobel Biocare Procera Recalls Two Dental Implant Crowns for Specification Defects
Nobel Biocare Procera LLC is recalling two dental implant crown units because they were not manufactured to specification. The affected units were distributed in the US and several international countries.
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 source text explicitly states no illnesses or injuries have been reported, limiting the score to 2 per the rubric for voluntary precautionary recalls without reported harm.
Plain-English summary
Nobel Biocare Procera LLC is recalling two units of the NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 dental implant crown. The recall was initiated because the products were not manufactured to specification. The affected units have serial numbers 173943674 and 173943711.
The recalled implant crowns are intended to be placed in the upper or lower jaw to restore chewing function and esthetics. The distribution pattern includes the United States (specifically Alabama, California, Oklahoma, and Washington) and the countries of Belgium, Canada, Italy, Sweden, and Switzerland.
Consumers and healthcare providers who possess these specific serial numbers should contact the recalling firm for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339
- Manufacturer
- Nobel Biocare Procera LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 2
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)
- Serial Numbers: 173943674
- 173943711
Distribution
Part of a larger recall action
This product is one of 5 recalled by Nobel Biocare Procera 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Nobel Biocare Procera LLC
See all →- ModerateNobel Biocare Procera Implant Crown Recalled for Manufacturing Defect
FDA (Devices) · 2021-06-02
- ModerateNobel Biocare Procera Implant Crown Recall for Manufacturing Defects
FDA (Devices) · 2021-06-02
- ModerateNobel Biocare Procera LLC Recalls Implant Crowns Not Manufactured to Specification
FDA (Devices) · 2021-06-02
- ModerateNobel Biocare Implant Crown Recalled for Manufacturing Specification Defects
FDA (Devices) · 2021-06-02
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