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

• Date Initiated by Firm: November 06, 2009
• Date Posted: December 10, 2009
• Recall Status: Terminated 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/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 760-929-4107
• Manufacturer Reason for Recall: The devices may not meet specifications, which may result in fracturing during tightening of the component.
• FDA Determined 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.
• 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