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U.S. Department of Health and Human Services

Class 2 Device Recall Dental implant

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 Class 2 Recall
Dental implant
see related information
Date Posted November 16, 2012
Recall Status1 Open
Recall Number Z-0298-2013
Recall Event ID 63618
Premarket Notification
510(K) Number
K100724 
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Code Information Model Number IFOA411, Lot # 2011111333, 2011111333-S1
Recalling Firm/
Manufacturer
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens, Florida 33410-4200
For Additional Information Contact Mark Mashburn
800-342-5454
Manufacturer Reason
for Recall
Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Biomet 3i sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 28, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this notice.
Quantity in Commerce 76 devices
Distribution Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France.
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, INC.
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