Nobel Biocare Procera Implant Crown Recalled for Manufacturing Defect
Nobel Biocare Procera LLC is recalling specific implant crown units that 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a manufacturing defect without reported harm, fitting the Moderate category for low-risk or precautionary issues.
Plain-English summary
Nobel Biocare Procera LLC is recalling the NPr FCZ¿Imp Crwn ASC CC RP 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 product was not manufactured to specification.
The affected product is identified by Material Number 77364 and Serial Number 173943753. The recall covers one unit. Distribution was worldwide, including US nationwide distribution in the states of Alabama, California, Oklahoma, and Washington, as well as in Belgium, Canada, Italy, Sweden, and Switzerland.
Consumers and healthcare providers should check their inventory for the specific serial number listed. If the product is found, it should be removed from use and returned to the manufacturer or a designated distributor for credit or replacement, in accordance with standard recall procedures.
The recalled product
- Product
- NPr FCZ¿Imp Crwn ASC CC RP 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: 77364
- 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: 173943753
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 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
- ModerateNobel Biocare Implant Crown Recalled for Manufacturing Specification Defects
FDA (Devices) · 2021-06-02
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