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U.S. Department of Health and Human Services

Class 2 Device Recall Nobel

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  Class 2 Device Recall Nobel see related information
Date Initiated by Firm March 29, 2021
Create Date May 25, 2021
Recall Status1 Terminated 3 on September 01, 2021
Recall Number Z-1679-2021
Recall Event ID 87848
510(K)Number K132746  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product 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
Code Information Serial Numbers:  173940845
Recalling Firm/
Manufacturer		 Nobel Biocare Procera LLC
800 Corporate Dr
Mahwah NJ 07430-2011
Manufacturer Reason
for Recall		 Not manufactured to specification
FDA Determined
Cause 2		 Process control
Action Nobel Dental notified US customers via phone by North American Customer Service on 3/29/21 and informed which device[s] was affected and that the device[s] had not been processed properly. Email communication was also distributed with a return label. Please find attached the return label for order XXXX to be returned to our manufacturing facility. We sincerely apologize for the inconvenience that this delay has caused. With the new order we are taking all possible actions to have it to you as soon as possible, while still ensuring the premium quality that you expect. The EMEA customer service/sales representatives were contacted by North America Customer Service.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NHA and Original Applicant = NOBEL BIOCARE USA, LLC
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