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U.S. Department of Health and Human Services

Class 3 Device Recall The Maestro System 204503, Straight Permucosal Ext, 5mm x 3mm

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 Class 3 Device Recall The Maestro System 204503, Straight Permucosal Ext, 5mm x 3mmsee related information
Date Initiated by FirmJune 03, 2005
Date PostedJune 23, 2005
Recall Status1 Terminated 3 on August 11, 2005
Recall NumberZ-0925-05
Recall Event ID 32335
Product Classification Accessories, Implant, Dental, Endosseous - Product Code NDP
ProductThe Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
Code Information Lot No. C0205048
Recalling Firm/
Manufacturer		 BioHorizons Implant Systems Inc
One Perimeter Park South
Suite 230, South
Birmingham AL 35243
For Additional Information ContactWinston Greer
205-986-1205
Manufacturer Reason
for Recall		The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce5 units
DistributionPA, TX, MI, VA and Russia
Total Product Life CycleTPLC 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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