Nobel Biocare Procera LLC 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Nobel Biocare Procera LLC
Lot Codes / Batch Numbers
Serial Numbers: 173940845
Products Sold
Serial Numbers: 173940845
Nobel Biocare Procera LLC is recalling NPr FCZImp Crwn ASC CC NP CAD 1-25 s4 - Product Usage: Implant Crown intended to be placed in the up due to Not manufactured to specification. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Not manufactured to specification
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026