BEUDAMED
    FDA Enforcement Class II Terminated

    CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4

    Recall: Z-0075-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0075-2021
    Event ID
    86402
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    August 31, 2020
    Classification Date
    October 8, 2020
    Termination Date
    July 6, 2022
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4

    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

    Code Info

    Lot Numbers: 8563336-1 8563892-1 8563910-1 8565718-2 8571887-1 8571887-2 8571887-3 8572668-1 8572668-2 UDI: (01)00844868031147(10)8563336-1 (01)00844868031147(10)8563892-1 (01)00844868031147(10)8563910-1 (01)00844868031147(10)8565718-2 (01)00844868031147(10)8571887-1 (01)00844868031147(10)8571887-2 (01)00844868031147(10)8571887-3 (01)00844868031147(10)8572668-1 (01)00844868031147(10)8572668-2

    Distribution

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

    Quantity

    9 units