Recall Z-0252-2007 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
| Date | Dec 6, 2006 (initiated Dec 28, 2005) |
| Status | Terminated |
| Reason | Dental implants were distributed which lacked the proper instruments for implantation. |
| Root cause | Other |
| Action | The firm initiated a recall on December 28, 2005 via US Mail. The letter explains the new implants introduced and explains the need for two additional instruments, the Handpiece and Ratchet Adapter, which are necessary to implant the new one-piece, ball-top 3.0mm diameter implant. A second letter was sent to all non-responding consignees on October 20, 2006 stating the same. The distributors were notified by electronic mail on 11/01/2006. |
| Quantity | 470 units |
| Distribution | Worldwide, including USA, Australia, Brazil, Canada, Chile, Colombia, Egypt, El Salvador, India, Israel, Italy, Ireland, Germany, Japan, Kuwait, Latvia, Lithuania, Mexico, Romania, Russia, Singapore, South Africa, Taiwan, United Arab Emirates, and United Kingdom. |
| 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 |