BEUDAMED
    FDA Recall Terminated

    BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ

    Recall: Z-0073-2021 · Initiated August 31, 2020

    Recall

    Recall Number
    Z-0073-2021
    Event Number
    86402
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 31, 2020
    Terminated
    July 6, 2022
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ

    Reason

    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

    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 [email protected]. 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 [email protected].

    Distribution

    FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA

    Quantity

    7 stand alone units