Z-0801-2007

Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant...

Name: Z-0801-2007 Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant...
Creator: BioHorizons Implant Systems Inc
Published: 2007-04-18
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2007-04-18 / Terminated

FDA source

BioHorizons Implant Systems Inc began a recall of Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243 on 2007-04-18. The reason FDA records is "Dental implant system is missing ball attachment system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0801-2007
Status: Terminated
Initiated: 2007-04-18
Posted: 2007-05-11
Terminated: 2007-08-11
Recalling firm: BioHorizons Implant Systems Inc
Product: Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Dental implant system is missing ball attachment system.
FDA 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 in commerce: 34 units
Distribution: Worldwide distribution ---- USA and country of Italy
Product codes and lots: Lot No. S0207053

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)