Class 3 Device Recall Biohorizons 3.0mm Overdenture Implant System

• Date Initiated by Firm: April 18, 2007
• Date Posted: May 11, 2007
• Recall Status: Terminated on August 11, 2007
• Recall Number: Z-0801-2007
• Recall Event ID: 37893
• 510(K)Number: K041938
• Product Classification: Dental Implant system - Product Code DZE
• Product: Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
• Code Information: Lot No. S0207053
• Recalling Firm/ Manufacturer: BioHorizons Implant Systems Inc; One Perimeter Park South; Suite 230, South; Birmingham AL 35243
• For Additional Information Contact: Winston Greer; 205-967-7880
• Manufacturer Reason for Recall: Dental implant system is missing ball attachment system.
• FDA Determined Cause: Other
• Action: Letters explaining the problem and MBAS systems were sent via United Parcel Service (UPS) 3rd day package delivery to the consignees (both domestic and abroad) on 04/18/2007.
• Quantity in Commerce: 34 units
• Distribution: Worldwide distribution ---- USA and country of Italy
• 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