Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1681-2021·Announced 2021-06-02

Nobel Biocare Procera LLC Recalls Implant Crowns Not Manufactured to Specification

Nobel Biocare Procera LLC is recalling specific implant crowns because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Nobel Biocare Procera LLC is recalling the NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 implant crown, Material Number 77387. The recall was initiated because the product was not manufactured to specification. The affected product is an implant crown intended to be placed in the upper or lower jaw to create a prosthetic device that restores chewing function and esthetics.

The recall includes units with Serial Number 173942675. These products were distributed worldwide, including nationwide distribution in the United States in the states of Alabama, California, Oklahoma, and Washington. International distribution occurred in Belgium, Canada, Italy, Sweden, and Switzerland.

The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare providers should stop using the affected implant crowns and contact the recalling firm for further instructions.

The recalled product

Product: NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - 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: 77387
Manufacturer: Nobel Biocare Procera LLC
Category: Medical Device — Dental Implant
Hazard: manufacturing-defect

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: 173942675

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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 →

Same manufacturer · Nobel Biocare Procera LLC

See all →

Moderate
Nobel Biocare Procera Implant Crown Recalled for Manufacturing Defect
FDA (Devices) · 2021-06-02
Moderate
Nobel Biocare Procera Recalls Two Dental Implant Crowns for Specification Defects
FDA (Devices) · 2021-06-02
Moderate
Nobel Biocare Procera Implant Crown Recall for Manufacturing Defects
FDA (Devices) · 2021-06-02
Moderate
Nobel Biocare Implant Crown Recalled for Manufacturing Specification Defects
FDA (Devices) · 2021-06-02

Same hazard · manufacturing defect