Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
FDA device recall Z-0499-2010 · posted 2009-12-10 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The devices may not meet specifications, which may result in fracturing during tightening of the component.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 738
- Distribution
- Ohio, Canada and France.
- Date initiated
- 2009-11-06
- Date posted
- 2009-12-10
- Date terminated
- 2010-10-08
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT (K061410) | Zimmer Dental, Inc. | 2006-09-08 |