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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 Recall
T3 Dental Implant
see related information
Date Posted August 13, 2013
Recall Status1 Open
Recall Number Z-1960-2013
Recall Event ID 65005
Premarket Notification
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, Florida 33410-4200
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = BIOMET 3I
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