Class 2 Device Recall BIOMET 3i

• Date Initiated by Firm: June 25, 2014
• Date Posted: September 05, 2014
• Recall Status: Terminated on September 23, 2014
• Recall Number: Z-2594-2014
• Recall Event ID: 68915
• 510(K)Number: K072642
• Product Classification: Abutment, implant, dental, endosseous - Product Code NHA
• Product: BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
• Code Information: Model Number IEHA458, Lot number: 1167545.
• FEI Number: 1038806
• 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: Identifiers on the label are correct but the label has the incorrect color coding.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Biomet 3i sent an Urgent - Medical Device Removal letter / and by phone call on and dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. If you have any Certain BellaTek Encode Healing Abutment(s) of the affected lot in your practice, please return the abutment(s) to BIOMET 3i in exchange for Cettain BellaTek Encode Healing Abutments, IEHA458 with a proper color stripe. Alternatively, you may return the Certain BellaTek Healing Abutment(s) for full credit. We also ask that you confirm receipt of this notification by completing the attached Recall Return Response Form, indicating your preference for replacement or credit and/ or notifying us if the product was used. Thank you for your support - we are committed to maintaining high standards of quality for all our products and apologize for any inconvenience this may have caused you. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.
• Quantity in Commerce: 6 units
• Distribution: US Distribution to NH and TX.
• 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 = NHA