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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Dental AdVent Implant System, Abutment, Tapered

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  Class 2 Device Recall Zimmer Dental AdVent Implant System, Abutment, Tapered see related information
Date Initiated by Firm November 06, 2009
Date Posted December 10, 2009
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-0499-2010
Recall Event ID 53813
510(K)Number K061410  
Product Classification Endosseous dental implant - Product Code DZE
Product Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
Code Information Lots 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
The devices may not meet specifications, which may result in fracturing during tightening of the component.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = ZIMMER DENTAL INC.