Nobel Biocare Procera LLC recalls 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 c…

Recall date

March 29, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1678-2021

FDA classification

Class II

Brand / firm

Nobel Biocare Procera LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.

Why it was recalled

Not manufactured to specification

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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