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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 August 03, 2012
Date Posted October 23, 2012
Recall Status1 Terminated 3 on December 20, 2012
Recall Number Z-0119-2013
Recall Event ID 63313
510(K)Number K063341  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Osseotite Tapered Certain Implant 5 X 10mm Model INT510

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 Model # INT510, Lot # 2011090751
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Mark Mashburn
561-776-6700
Manufacturer Reason
for Recall		 Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
FDA Determined
Cause 2		 Process control
Action Biomet 3 i sent an Urgent Medical Device Recall letter dated August 3, 2012, to all affected customers via e-mail, facsimile, telephone, or postal mail. Each customer was instructed to check their inventory for the affected product and provide feedback to Biomet 3i. Product is to be returned to: Biomet 3i P.M. Regulatory Compliance 4555 Riverside Drive Palm Beach Gardens, Florida 33410 For questions customers were instructed to call 1-800-342-5454. For questions regarding this recall call 561-776-6700.
Quantity in Commerce 227
Distribution Worldwide Distribution - USA including PA, GA, OR, KS, NY, VA, CT, NH, IL, OK, and MA and internationally to Australia, Brazil, Columbia, France, Germany, Ireland, Italy, Japan, Paraguay, Portugal, and Spain.
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.
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