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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/
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 2		 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 and Original Applicant = BIOHORIZONS IMPLANT SYSTEMS, INC.
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