BEUDAMED
    FDA Recall Terminated

    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474

    Recall: Z-1381-2020 · Initiated January 10, 2020

    Recall

    Recall Number
    Z-1381-2020
    Event Number
    84771
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 10, 2020
    Terminated
    August 2, 2021
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474

    Reason

    Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment

    Action

    Zimmer Biomet issued letter to Distributors, Clinicians via FedX on 1/10/20 stating reason for recall, health risk and action take: Step 1: Quarantine any unused affected products in your inventory for return to Zimmer Biomet Dental. Step 2: Identify any patients currently in your care who have received an affected Certain Encode Healing Abutment with the lot numbers in Table 1. a)If the lot number of the Certain BellaTek Encode Healing Abutment is known: a.If the patient has not yet undergone scanning/impressioning, the affected Certain BellaTek Encode Healing Abutment should be replaced with a new Certain BellaTek Encode Healing Abutment prior to scanning/impressioning. Please contact Zimmer Biomet Dental at the number provided in Step G below for an immediate replacement Certain BellaTek Encode Healing Abutment. b.If the case has already been started and the scan/impression has been sent to a lab, please ask the lab to call BellaTek Customer Service team at the number referenced in Step G below for instructions on how to remediate the case. The lab will not be charged twice for the BellaTek abutment. b)If the lot number of the Certain BellaTek Encode Healing Abutment is unknown, inspect for the product condition using Attachment 2. a.If the referenced product condition is present, please follow the instructions in Step 2a above. The affected healing abutment must be returned to Zimmer Biomet Dental per the below instructions. b.If the referenced condition is not present, reinsert the original healing abutment and release the patient. Complete certificate of Acknowledgement and email to [email protected]. Questions or concerns call the BellaTek Customer Service team at 1-888-800-8045 between 8:00 am and 5:00pm EST, Monday through Friday.

    Distribution

    Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK