Class 2 Device Recall Zimmer Dental Calcitite 40602

• Date Initiated by Firm: January 22, 2009
• Date Posted: February 06, 2009
• Recall Status: Terminated on October 23, 2009
• Recall Number: Z-0974-2009
• Recall Event ID: 50887
• 510(K)Number: K811101
• Product Classification: HYDROXYLAPATITE - Product Code LYC
• Product: Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003. Device is used for filling of periodontal defects following conventional curettage and debridement. The device is also indicated for the esthetic repair of bony defects of the alveolar ridge beneath new or existing fixed prosthetic restorations.
• Code Information: Lots 60864773, 60879983 and 60967942.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-854-7019
• Manufacturer Reason for Recall: Fragments of the glass vial may be present in some of the packages from these lots.
• FDA Determined Cause: Packaging process control
• Action: The consignee in Japan was notified by e-mail and "Urgent: Device Recall" letter dated January 22, 2009 to stop using the product and to return it to the firm.
• Quantity in Commerce: 225 kits
• Distribution: International Distribution including the country of Japan.
• 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 = LYC