Class 3 Device Recall 3 i Implant Innovations, Inc.

• Date Initiated by Firm: January 28, 2003
• Date Posted: March 20, 2003
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0665-03
• Recall Event ID: 25722
• 510(K)Number: K950204
• Product Classification: Implant, Endosseous, Root-Form - Product Code DZE
• Product: LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,
• Code Information: For LTX 611 lot number 150102P For LTX 515 lot number 150100P
• Recalling Firm/ Manufacturer: Implant Innovations, Inc.; 4555 Riverside Dr; Palm Beach Gardens FL 33410
• For Additional Information Contact: Jacquelyn A. Hughes, RAC; 800-443-8166
• Manufacturer Reason for Recall: Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
• FDA Determined Cause: Other
• Action: The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information.
• Quantity in Commerce: 68
• Distribution: Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and 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