Z-0252-2007

BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit

Name: Z-0252-2007 BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
Creator: BioHorizons Implant Systems Inc
Published: 2005-12-28
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2005-12-28 / Terminated

FDA source

BioHorizons Implant Systems Inc began a recall of BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit on 2005-12-28. The reason FDA records is "Dental implants were distributed which lacked the proper instruments for implantation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0252-2007
Status: Terminated
Initiated: 2005-12-28
Posted: 2006-12-06
Terminated: 2007-08-11
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
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Dental implants were distributed which lacked the proper instruments for implantation.
FDA 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 in commerce: 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.
Product codes and lots: Lot Nos.: K1103005, K1203002, K1203006, K0104001, K0104004, K0104005, K0204001, K0204007, K0204008, K0304001, K0304007, K0404001, K0404008, K0504003, K0604003, K0704002,

Product code DZE

K041938Class IIMaximus Os (Overdenture System)BioHorizons Implant Systems, Inc. / cleared 2004-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)