Recall Z-0801-2007 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
| Date | May 11, 2007 (initiated Apr 18, 2007) |
| Status | Terminated |
| Reason | Dental implant system is missing ball attachment system. |
| Root cause | Other |
| Action | Letters explaining the problem and MBAS systems were sent via United Parcel Service (UPS) 3rd day package delivery to the consignees (both domestic and abroad) on 04/18/2007. |
| Quantity | 34 units |
| Distribution | Worldwide distribution ---- USA and country of Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041938 | MAXIMUS OS (OVERDENTURE SYSTEM) BioHorizons Implant Systems, Inc., Jul 22, 2004 |