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U.S. Department of Health and Human Services

Class 3 Device Recall The Maestro System 225312, Profile Abutment for Cement, 5mm

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  Class 3 Device Recall The Maestro System 225312, Profile Abutment for Cement, 5mm see related information
Date Initiated by Firm June 03, 2005
Date Posted June 23, 2005
Recall Status1 Terminated 3 on August 11, 2005
Recall Number Z-0926-05
Recall Event ID 32335
Product Classification Accessories, Implant, Dental, Endosseous - Product Code NDP
Product The Maestor System 225-312, Profile Abutment for Cement, 5mm
Code Information Lot No. C0205065
Recalling Firm/
Manufacturer		 BioHorizons Implant Systems Inc
One Perimeter Park South
Suite 230, South
Birmingham AL 35243
For Additional Information Contact Winston Greer
205-986-1205
Manufacturer Reason
for Recall		 The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.
FDA Determined
Cause 2		 Other
Action The domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action.
Quantity in Commerce 23 units
Distribution PA, TX, MI, VA and Russia
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.
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