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U.S. Department of Health and Human Services

Class 2 Device Recall Endosseous Dental Implants

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  Class 2 Device Recall Endosseous Dental Implants see related information
Date Initiated by Firm November 04, 2011
Date Posted June 20, 2012
Recall Status1 Terminated 3 on June 25, 2012
Recall Number Z-1828-2012
Recall Event ID 61376
510(K)Number K063341  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. .

Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.***

Product Usage:
The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of 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 Lot #2010111529
Recalling Firm/
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Alfredo Ferrer
Manufacturer Reason
for Recall
On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
FDA Determined
Cause 2
Device Design
Action Biomet 3i sent an Urgent: Medical Device Recall letter dated November 04, 2011 via e-mail, facsimile, telephone or postal mail to all consignees affected. The letter identified the affected product, problem and actions to be taken. Each customer was instructed to check their respective inventory for the affected product and return any unused item(s) to Biomet 3i for prompt replacement. For question or concerns contact Biomet 3i at 1-800-342-5454.
Quantity in Commerce 219 units in total
Distribution Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.
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 = IMPLANT INNOVATIONS, INC.