Nobel Biocare Implant Crown Recalled for Manufacturing Specification Defects
Nobel Biocare Procera LLC is recalling specific implant crown units because they were not manufactured to specification. The recall affects units 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. The source text cites 'not manufactured to specification' as the reason, with no reported injuries, illnesses, or specific functional hazards described, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Nobel Biocare Procera LLC is recalling specific units of the NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 implant crown. The product is intended to be placed in the upper or lower jaw to create a prosthetic device that restores chewing function and esthetics. The recall is being conducted because the affected units were not manufactured to specification.
The recall affects one unit with Serial Number 173940845. These products were distributed worldwide, including in the United States (Alabama, California, Oklahoma, and Washington) and in Belgium, Canada, Italy, Sweden, and Switzerland.
Consumers and healthcare providers who have this specific product should contact Nobel Biocare Procera LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - 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: 77363
- Manufacturer
- Nobel Biocare Procera LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 1
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 (1)
- Serial Numbers: 173940845
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 Recalls Two Dental Implant Crowns for Specification Defects
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
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