The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1678-2021·Announced 2021-06-02

Nobel Biocare Procera Implant Crown Recall for Manufacturing Defects

Nobel Biocare Procera LLC is recalling seven implant crown units because they were not manufactured to specification. The recall covers distribution 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 rating.

Plain-English summary

Nobel Biocare Procera LLC is recalling seven units of the NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 implant crown. These devices are 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 products were not manufactured to specification.

The affected units have the following serial numbers: 173939852, 173940027, 173940107, 173940346, 173940844, 173940852, and 173942662. The material number for these products is 77352.

The recall involves worldwide distribution, including US nationwide distribution in the states of Alabama, California, Oklahoma, and Washington, as well as distribution in Belgium, Canada, Italy, Sweden, and Switzerland. The source text does not specify the required actions for consumers or healthcare providers.

The recalled product

Product
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - 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: 77352
Manufacturer
Nobel Biocare Procera LLC
Category
Medical Device — Dental Implant
Hazard
Affected units
7

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 (7)

  • Serial Numbers: 173939852
  • 173940027
  • 173940107
  • 173940346
  • 173940844
  • 173940852
  • 173942662

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 →

Related recalls

Same manufacturer · Nobel Biocare Procera LLC

See all →

Same hazard · manufacturing defect

See all →

Similar recalls