FDA Medical Device Recalls (openFDA)
BioHorizons Implant Systems Inc: BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
- Recall number
- Z-0252-2007
- Recalling firm
- BioHorizons Implant Systems Inc
- Product
- BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
- Status
- Terminated
- Initiated
- 2005-12-28
- Posted
- 2006-12-06
- Terminated
- 2007-08-11
- 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.
- Lot, serial or model codes
- Lot Nos.: K1103005, K1203002, K1203006, K0104001, K0104004, K0104005, K0204001, K0204007, K0204008, K0304001, K0304007, K0404001, K0404008, K0504003, K0604003, K0704002,
- 510(k) numbers
- ["K041938"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1000592496
- Firm city
- Birmingham
- Firm state
- AL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28