Z-0925-05

The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm

Name: Z-0925-05 The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
Creator: BioHorizons Implant Systems Inc
Published: 2005-06-03
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2005-06-03 / Terminated / root cause: labeling and UDI

FDA source

BioHorizons Implant Systems Inc began a recall of The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm on 2005-06-03. The reason FDA records is "The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0925-05
Status: Terminated
Initiated: 2005-06-03
Posted: 2005-06-23
Terminated: 2005-08-11
Recalling firm: BioHorizons Implant Systems Inc
Product: The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action.
Quantity in commerce: 5 units
Distribution: PA, TX, MI, VA and Russia
Product codes and lots: Lot No. C0205048

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)