Class 2 Device Recall Full OSSEOTITE Tapered Certain Implant

• Date Initiated by Firm: March 23, 2012
• Date Posted: August 08, 2012
• Recall Status: Terminated on December 16, 2013
• Recall Number: Z-2158-2012
• Recall Event ID: 62375
• 510(K)Number: K063341
• Product Classification: Abutment, implant, dental, endosseous - Product Code NHA
• Product: ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.
• Code Information: Lot Number 2011110798
• Recalling Firm/ Manufacturer: Biomet 3i, LLC; 4555 Riverside Dr; Palm Beach Gardens FL 33410-4200
• For Additional Information Contact: 561-776-6700
• Manufacturer Reason for Recall: Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
• FDA Determined Cause: Process control
• Action: BIOMET 3i sent an Urgent Medical Device Recall letter on March 19, 2012, to all affected customers via email or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers are to return any unopened and unused product for replacement at no cost. In addition, customers should contact Customer Service at 1-800-342-5454 for assistance if they encounter issues with the mating component, or if they have any questions or concerns. Customers are to respond to the notification regardless of whether they have product to return.
• Quantity in Commerce: 240
• Distribution: Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.
• 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 = NHA