BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
FDA device recall Z-0252-2007 · posted 2006-12-06 · Terminated
Recall details
- Recalling firm
- BioHorizons Implant Systems Inc
- Reason for recall
- Dental implants were distributed which lacked the proper instruments for implantation.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 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,
- Date initiated
- 2005-12-28
- Date posted
- 2006-12-06
- Date terminated
- 2007-08-11
- Location
- Birmingham, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXIMUS OS (OVERDENTURE SYSTEM) (K041938) | BioHorizons Implant Systems, Inc. | 2004-07-22 |