Recall Z-1388-2020 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
| Date | Jan 10, 2020 |
| Status | Terminated |
| Reason | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment |
| Root cause | Process control |
| Action | Zimmer Biomet issued letter to Distributors, Clinicians via FedX on 1/10/20 stating reason for recall, health risk and action take: Step 1: Quarantine any unused affected products in your inventory for return to Zimmer Biomet Dental. Step 2: Identify any patients currently in your care who have received an affected Certain Encode Healing Abutment with the lot numbers in Table 1. a)If the lot number of the Certain BellaTek Encode Healing Abutment is known: a.If the patient has not yet undergone scanning/impressioning, the affected Certain BellaTek Encode Healing Abutment should be replaced wi |
| Distribution | Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS Biomet 3i, Inc., Dec 20, 2007 |