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Terminated

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

FDA Recall Z-0499-2010 · Posted 2009-12-10

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2009-11-06
Date Terminated2010-10-08
Product Quantity738

Reason for Recall

The devices may not meet specifications, which may result in fracturing during tightening of the component.

Firm 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.

Root Cause

Process control

Distribution Pattern

Ohio, Canada and France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061410SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANTZimmer Dental, Inc. · 2006-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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