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U.S. Department of Health and Human Services

Class 3 Device Recall Biohorizons Maximus surgical kit

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  Class 3 Device Recall Biohorizons Maximus surgical kit see related information
Date Initiated by Firm December 28, 2005
Date Posted December 06, 2006
Recall Status1 Terminated 3 on August 11, 2007
Recall Number Z-0252-2007
Recall Event ID 36764
510(K)Number K041938  
Product Classification dental implant - Product Code DZE
Product BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
Code Information Lot Nos.: K1103005, K1203002, K1203006, K0104001, K0104004, K0104005, K0204001, K0204007, K0204008, K0304001, K0304007, K0404001, K0404008, K0504003, K0604003, K0704002,
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 implants were distributed which lacked the proper instruments for implantation.
FDA Determined
Cause 2		 Other
Action The firm initiated a recall on December 28, 2005 via US Mail. The letter explains the new implants introduced and explains the need for two additional instruments, the Handpiece and Ratchet Adapter, which are necessary to implant the new one-piece, ball-top 3.0mm diameter implant. A second letter was sent to all non-responding consignees on October 20, 2006 stating the same. The distributors were notified by electronic mail on 11/01/2006.
Quantity in Commerce 470 units
Distribution Worldwide, including USA, Australia, Brazil, Canada, Chile, Colombia, Egypt, El Salvador, India, Israel, Italy, Ireland, Germany, Japan, Kuwait, Latvia, Lithuania, Mexico, Romania, Russia, Singapore, South Africa, Taiwan, United Arab Emirates, and United Kingdom.
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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