Recall Z-2760-2015 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
| Date | Sep 11, 2015 (initiated Jul 29, 2015) |
| Status | Terminated |
| Reason | MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only. |
| Root cause | Process control |
| Action | Biomet sent a Medical Device Recall Notice dated July 27, 2015, to all their clinicians informing them about the recall and to complete the attached recall return response form and any unused product to be replaced at no charge. Contact information 1-800-342-5454 |
| Quantity | 61 pieces |
| Distribution | Worldwide Distribution including Italy and Uruguay. |
| 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 |