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U.S. Department of Health and Human Services

Class 3 Device Recall Biohorizons 3.0mm Overdenture Implant System

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  Class 3 Device Recall Biohorizons 3.0mm Overdenture Implant System see related information
Date Initiated by Firm April 18, 2007
Date Posted May 11, 2007
Recall Status1 Terminated 3 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/
BioHorizons Implant Systems Inc
One Perimeter Park South
Suite 230, South
Birmingham AL 35243
For Additional Information Contact Winston Greer
Manufacturer Reason
for Recall
Dental implant system is missing ball attachment system.
FDA Determined
Cause 2
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 and Original Applicant = BIOHORIZONS IMPLANT SYSTEMS, INC.