Class 2 Device Recall BellaTek Encode

• Date Initiated by Firm: August 31, 2020
• Create Date: October 08, 2020
• Recall Status: Terminated on July 06, 2022
• Recall Number: Z-0073-2021
• Recall Event ID: 86402
• 510(K)Number: K052648
• Product Classification: Abutment, implant, dental, endosseous - Product Code NHA
• Product: BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
• Code Information: Reference Number: 3DPMSER Lot Numbers: 8560249-1 8564285-1 8570989-1 Reference Number: 3DPMSERQ Lot Numbers: 8561588-1 8561591-1 8569150-1 8570607-1
• Recalling Firm/ Manufacturer: Biomet 3i, LLC; 4555 Riverside Dr; Palm Beach Gardens FL 33410-4200
• For Additional Information Contact: Customer Service; 888-800-8045
• Manufacturer Reason for Recall: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
• FDA Determined Cause: Device Design
• Action: Zimmer Biomet issued Urgent Medical Device Recall letter dated 8/31/2020 to Dental Labs and Clinicians stating reason for recall, health risk and action to take: Quarantine any affected products (definitive BellaTek abutments/3D printed models) from Attachment 1 in your possession for return to Zimmer Biomet Dental. 2. Identify any clinicians who have received an affected BellaTek Definitive Abutment as identified in Attachment 1. 3. For clinicians that have received an affected BellaTek Definitive Abutment from you, provide a copy of this notice to them along with Attachment 3 for them to complete. B. Certificate of Acknowledgement 1. Complete Attachment 2  Certificate of Acknowledgement and email to orporateQuality.PostMarket@zimmerbiomet.com. Return of product 1. Include a copy of Attachment 2 Certificate of Acknowledgement with any product tobe returned. Using the return shipping label included with this notice, please returnaffected product to the address below. Customer Service will provide additionalshipping labels if needed. Field Action PM Regulatory Compliance Zimmer Biomet 4555 Riverside Dr. Palm Beach Gardens, FL 33410 US D. Retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilitys documentation. E. If you have any questions after reviewing this notice, please call or email the Customer Service team at: 1-888-800-8045 or DentalCSDigital@ZimmerBiomet.com.
• Quantity in Commerce: 7 stand alone units
• Distribution: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
• 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