Class 2 Device Recall LTX XP Miniplant

• Date Initiated by Firm: August 03, 2007
• Date Posted: September 18, 2007
• Recall Status: Terminated on September 11, 2009
• Recall Number: Z-1221-2007
• Recall Event ID: 38983
• 510(K)Number: K063286 K950204
• Product Classification: Dental Implant - Product Code DZE
• Product: Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.
• Code Information: Model No. LTX3211 - Packaged Lot No. 606199 Model No. LTX3213 - Packaged Lot No. 606191
• FEI Number: 1038806
• Recalling Firm/ Manufacturer: Biomet 3i; 4555 Riverside Drive; Palm Beach Gardens FL 33410-4200
• For Additional Information Contact: 561-776-6700 Ext. 6819
• Manufacturer Reason for Recall: The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.
• FDA Determined Cause: Labeling mix-ups
• Action: International customers were contacted first by e-mail , then by fax letter 08/03/2007.
• Quantity in Commerce: 240 (120 each model / lot)
• Distribution: Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, Chile.
• 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