Recall Z-0079-2021 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
| Date | Aug 31, 2020 |
| Status | Terminated |
| Reason | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient |
| Root cause | Device Design |
| Action | Zimmer Biomet issued Urgent Medical Device Recall letter dated 8/31/2020 to Dental Labs and Clinicians stating reason for recall, health risk and action to take: Quarantine any affected products (definitive BellaTek abutments/3D printed models) from Attachment 1 in your possession for return to Zimmer Biomet Dental. 2. Identify any clinicians who have received an affected BellaTek Definitive Abutment as identified in Attachment 1. 3. For clinicians that have received an affected BellaTek Definitive Abutment from you, provide a copy of this notice to them along with Attachment 3 for them to com |
| Quantity | 1 unit |
| Distribution | FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052648 | MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS Implant Innovations, Inc., Oct 20, 2005 |