Z-0231-2007

XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)

Name: Z-0231-2007 XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)
Creator: Dentsply Friadent Ceramed
Published: 2006-11-17
License: https://open.fda.gov/license/

Dentsply Friadent Ceramed / initiated 2006-11-17 / Terminated / root cause: packaging

FDA source

Dentsply Friadent Ceramed began a recall of XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant) on 2006-11-17. The reason FDA records is "Sterility of dental implants may be compromised due to cracks in packaging/caps on vials". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0231-2007
Status: Terminated
Initiated: 2006-11-17
Posted: 2006-12-01
Terminated: 2007-04-30
Recalling firm: Dentsply Friadent Ceramed
Product: XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product.
Quantity in commerce: 1685 units
Distribution: Worldwide-USA and one Canadian consignee.
Product codes and lots: Model # 26-0123

Product code DZE

K032750Class IIModification to: Xive 3.0 Dental Implant System, MultipleFriandent GmbH / cleared 2003-10-02

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)