Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Recalled by Nobel Biocare Procera LLC Due to Not manufactured to specification

Date: March 29, 2021
Company: Nobel Biocare Procera LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nobel Biocare Procera LLC directly.

Affected Products

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

Quantity: 2 units

Why Was This Recalled?

Not manufactured to specification

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nobel Biocare Procera LLC

Nobel Biocare Procera LLC has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report