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U.S. Department of Health and Human Services

Class 2 Device Recall Osseotite, 2Certain, Prevail

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 Class 2 Device Recall Osseotite, 2Certain, Prevail see related information
Date Posted September 16, 2013
Recall Status1 Terminated on November 06, 2014
Recall Number Z-2207-2013
Recall Event ID 66204
510(K)Number K100724 
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (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 XIIOS5411
Recalling Firm/
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact
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
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 215
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 = BIOMET 3I, INC.