Recall Z-1680-2021 ยท NHA Abutment, Implant, Dental, Endosseous
Nobel Biocare Procera LLC
NPr FCZImp Crwn ASC CC RP 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: 77364
| Date | Mar 29, 2021 |
| Status | Terminated |
| Reason | Not manufactured to specification |
| Root cause | 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 servic |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION Nobel Biocare USA, LLC, Jan 30, 2014 |