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U.S. Department of Health and Human Services

Class 2 Device Recall Osseotite, Parallel Walled Certain

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 Class 2 Recall
Osseotite, Parallel Walled Certain
see related information
Date Posted September 16, 2013
Recall Status1 Open
Recall Number Z-2208-2013
Recall Event ID 66204
Premarket Notification
510(K) Number
K063341 
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide 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 IOSS415
Recalling Firm/
Manufacturer
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens, Florida 33410-4200
Manufacturer Reason
for Recall
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
FDA Determined
Cause 2
DESIGN: Device Design
Action Biomet 3i sent an Urgent: Medical Device Recall letter dated June 10, 2013 to affected customer via email, facsimile, or postal mail. The letter identified the affected product, problem, and actions to be taking. Customer were instructed to check their respective inventory for the affected product and return to Biomet 3i. Biomet 3i will issue replacement product. For questions or concerns call 1-800-342-5454.
Quantity in Commerce 178
Distribution Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom.
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 = IMPLANT INNOVATIONS, INC.
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