PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 2, 2021 Initiated: March 29, 2021 #Z-1679-2021

Product Description

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

Reason for Recall

Not manufactured to specification

Details

Recalling Firm
Nobel Biocare Procera LLC
Units Affected
1 unit
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Nobel Biocare Procera LLC. Units affected: 1 unit.
Why was this product recalled?
Not manufactured to specification
Which agency issued this recall?
This recall was issued by the FDA Devices on June 2, 2021. Severity: Moderate. Recall number: Z-1679-2021.