Recall Z-0230-2007 ยท DZE Implant, Endosseous, Root-Form
Dentsply Friadent Ceramed
XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant)
| Date | Dec 1, 2006 (initiated Nov 17, 2006) |
| Status | Terminated |
| Reason | Sterility of dental implants may be compromised due to cracks in packaging/caps on vials. |
| Root cause | Other |
| Action | Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product. |
| Quantity | 1685 units |
| Distribution | Worldwide-USA and one Canadian consignee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032750 | MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE Friandent GmbH, Oct 2, 2003 |