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Terminated

NPr FCZImp 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

FDA Recall Z-1679-2021 · Posted None

Recalling FirmNobel Biocare Procera LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2021-03-29
Date Terminated2021-09-01
Product Quantity1 unit

Reason for Recall

Not manufactured to specification

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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