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U.S. Department of Health and Human Services

Class 2 Device Recall Osseotite Certain Implant(s) & Osseotite Tapered Certain Implant(s)

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  Class 2 Device Recall Osseotite Certain Implant(s) & Osseotite Tapered Certain Implant(s) see related information
Date Initiated by Firm March 10, 2011
Date Posted May 04, 2011
Recall Status1 Terminated 3 on January 25, 2012
Recall Number Z-2139-2011
Recall Event ID 58326
Product Classification Dental implant surgical tray - Product Code O-FY
Product ***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***
Biomet 3i Dental Implants are intended for 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 Lot number: 2009110838.
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Alfredo Ferrer
561-776-6700
Manufacturer Reason
for Recall		 Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly.
FDA Determined
Cause 2		 Other
Action BIOMET 3i sent an Urgent Medical Device Recall Letter on March 14, 2011, to all affected customers via emial or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told to contact Customer Service at 1-800-342-5454. Customers were instructed to respond with the attached Response Fax or email DomesticComplaints@Biomet.com. If customers still had implant(s) in their inventory, they were to return the implant(s) to BIOMET 3i using the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CD117886 A replacement implant(s) will be sent to them one the product is returned. For questions regarding this recall call 561-776-6906 (EST 8:00am to 5:00pm).
Quantity in Commerce 217
Distribution Worldwide Distribution - USA including AK, FL, GA, NC, NJ, NY, SC and the countries of Canada, Europe, Japan, and South America.
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.
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