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U.S. Department of Health and Human Services

Class 2 Device Recall OSSEOTITE Certain Implant

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  Class 2 Device Recall OSSEOTITE Certain Implant see related information
Date Initiated by Firm November 18, 2010
Date Posted November 08, 2011
Recall Status1 Terminated 3 on November 09, 2011
Recall Number Z-0171-2012
Recall Event ID 58766
510(K)Number K100724  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 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. The Thread form titanium screws (cylindrical dental implants) designed to be placed into mandibular or maxillary jaws in order to affix a dental prosthesis (edentulous or partially edentulous segments) that replaces 1 or more missing teeth.
Code Information Lot #910695
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Maggie Anderson
561-776-6704
Manufacturer Reason
for Recall		 The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
FDA Determined
Cause 2		 Process control
Action The firm sent an Urgent: Medical Device Recall letter, dated November 2010, to notify customers that received the Osseotite Certain Implant (IOSS511) of the problem. The customers were instructed to return the unopened device(s) to Biomet 3i for replacement. If customers notice an issue, they were to contact Customer Service at 1-800-342-5454 for assistance. Customers were to respond via fax and return the implant(s) to BIOMET 3i using the address and incident number provided. Customers with questions or concerns were instructed to contact Mark Mashburn at 561-776-6906.
Quantity in Commerce 241
Distribution Worldwide Distribution -- USA , BR, JP, TW, CA, Germany, and Guam.
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.
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