Z-0499-2010

Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF...

Name: Z-0499-2010 Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF...
Creator: Zimmer Inc.
Published: 2009-11-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-11-06 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT on 2009-11-06. The reason FDA records is "The devices may not meet specifications, which may result in fracturing during tightening of the component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0499-2010
Status: Terminated
Initiated: 2009-11-06
Posted: 2009-12-10
Terminated: 2010-10-08
Recalling firm: Zimmer GmbH
Product: Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The devices may not meet specifications, which may result in fracturing during tightening of the component.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: User accounts were notified of the issue by phone on or about 11/6/09. Clinicians were requested to schedule a follow-up appointment and to remove and replace the recalled components for any patients who had this device placed without fracturing during the procedure. Questions are directed to the company at 1-800-854-7019.
Quantity in commerce: 738
Distribution: Ohio, Canada and France.
Product codes and lots: Lots 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224.

Product code DZE

K061410Class IIScrew-Vent Implant System, Sv;tapered Screw -Vent Implant System, Tsv;advent Implant System,av;zimmer One-Piece ImplantZimmer Dental, Inc. / cleared 2006-09-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)