XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant)
FDA device recall Z-0230-2007 · posted 2006-12-01 · Terminated
Recall details
- Recalling firm
- Dentsply Friadent Ceramed
- Reason for recall
- Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
- Action taken
- Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 1685 units
- Distribution
- Worldwide-USA and one Canadian consignee.
- Date initiated
- 2006-11-17
- Date posted
- 2006-12-01
- Date terminated
- 2007-04-30
- Location
- Lakewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE (K032750) | Friandent GmbH | 2003-10-02 |