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U.S. Department of Health and Human Services

Class 2 Device Recall T3 Dental Implant

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  Class 2 Device Recall T3 Dental Implant see related information
Date Initiated by Firm May 10, 2013
Date Posted August 13, 2013
Recall Status1 Terminated 3 on August 13, 2014
Recall Number Z-1960-2013
Recall Event ID 65005
510(K)Number K122300  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
Code Information Lot number: 2012111613 Exp 2017/12 Catalog #: BOPS6510
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact
561-776-6700
Manufacturer Reason
for Recall		 A small number of outer implant boxes may be mislabeled. The inner tray, containing the implant, is label correctly. This condition, if present and not recognized could potentially result in the dental implant not being able to be placed into the osteotomy or seated to the desired depth if placement is attempted.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm issued "Urgent Medical Device Recall" notification letters to their customers dated May 10, 2013. The notification described the issue and provided recommendations actions regarding affected product. Customers with questions may contact 1 800-342-5454.
Quantity in Commerce 51
Distribution Distribution to the state of Massachusetts, and the foreign countries of Australia, Belgium, Spain, Denmark, France, Luxembourg, Switzerland, Germany, Bonaire, Sweden, and 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 = BIOMET 3I
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