Class 2 Device Recall Dental implant

• Date Initiated by Firm: September 28, 2012
• Date Posted: November 16, 2012
• Recall Status: Terminated on August 06, 2015
• Recall Number: Z-0297-2013
• Recall Event ID: 63618
• 510(K)Number: K100724
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• Product: Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
• Code Information: Model Number XIFNT413, Lot # 2012040462
• Recalling Firm/ Manufacturer: Biomet 3i, LLC; 4555 Riverside Dr; Palm Beach Gardens FL 33410-4200
• For Additional Information Contact: Mark Mashburn; 800-342-5454
• Manufacturer Reason for Recall: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Biomet 3i sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 28, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this notice.
• Quantity in Commerce: 191 devices
• Distribution: Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, 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