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U.S. Department of Health and Human Services

Class 2 Device Recall OSSEOTITE Tapered Certain Implant

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  Class 2 Device Recall OSSEOTITE Tapered Certain Implant see related information
Date Initiated by Firm November 07, 2014
Date Posted April 10, 2015
Recall Status1 Terminated 3 on May 22, 2015
Recall Number Z-1410-2015
Recall Event ID 70628
510(K)Number K100724  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm.

Dental Implants.
Code Information Implant PN # IFNT3211 Lot # 2014051477 Exp date 12/06/2018
Recalling Firm/
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Mark Mashburn
Manufacturer Reason
for Recall
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
FDA Determined
Cause 2
Manufacturing material removal
Action Biomet 3i sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 7, 3014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
Quantity in Commerce 620 implants in total
Distribution Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
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 = BIOMET 3I, INC.