Class 2 Device Recall Osseotite Tapered Certain Implant

• Date Initiated by Firm: August 03, 2012
• Date Posted: October 23, 2012
• Recall Status: Terminated 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: 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