Class 2 Device Recall standard Abutment

• Date Initiated by Firm: October 04, 2004
• Date Posted: October 21, 2004
• Recall Status: Terminated on February 07, 2005
• Recall Number: Z-0029-05
• Recall Event ID: 30203
• 510(K)Number: K934126
• Product Classification: Implant, Endosseous, Root-Form - Product Code DZE
• Product: EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
• Code Information: Product Code: THA54 Lot No. 249229
• Recalling Firm/ Manufacturer: Implant Innovations, Inc.; 4555 Riverside Dr; Palm Beach Gardens FL 33410-4200
• Manufacturer Reason for Recall: The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
• FDA Determined Cause: Other
• Action: Begining on October 4, 2004 each direct account was contacted by email, faxed letter and telephone. They were informed of the recall and instructed to contact their customers if the product had been sold.
• Quantity in Commerce: 216 units
• Distribution: Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
• 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