Recall Z-1681-2021— Nobel Biocare Procera LLC

Name: FDA recall Z-1681-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-29

Class II · Terminated

Class II FDA medical device recall by Nobel Biocare Procera LLC, initiated 2021-03-29, terminated 2021-09-01. It names one FDA 510(k) clearance: K132746. 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. Reason: Not manufactured to specification.

Recalling firm: Nobel Biocare Procera LLC
Classification: Class II
Status: Terminated
Initiated: 2021-03-29
Terminated: 2021-09-01
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K132746 — NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTIONNobel Biocare USA, LLC·cleared 2014-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Not manufactured to specification

Data sourced from openFDA. This site is unofficial and independent of the FDA.