Date Initiated by Firm | March 29, 2021 |
Create Date | May 25, 2021 |
Recall Status1 |
Terminated 3 on September 01, 2021 |
Recall Number | Z-1681-2021 |
Recall Event ID |
87848 |
510(K)Number | K132746 |
Product Classification |
Abutment, implant, dental, endosseous - Product Code NHA
|
Product | NPr FCZImp 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 |
Code Information |
Serial Numbers: 173942675 |
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. |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = NHA
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