Recall Z-0499-2010 ยท DZE Implant, Endosseous, Root-Form
Zimmer Inc.
Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
| Date | Dec 10, 2009 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | The devices may not meet specifications, which may result in fracturing during tightening of the component. |
| Root cause | Process control |
| Action | User accounts were notified of the issue by phone on or about 11/6/09. Clinicians were requested to schedule a follow-up appointment and to remove and replace the recalled components for any patients who had this device placed without fracturing during the procedure. Questions are directed to the company at 1-800-854-7019. |
| Quantity | 738 |
| Distribution | Ohio, Canada and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061410 | SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT Zimmer Dental, Inc., Sep 8, 2006 |