BEUDAMED
    FDA Enforcement Class II Terminated

    NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012 0202265014

    Recall: Z-0304-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0304-2020
    Event ID
    83962
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2019
    Initiation Date
    October 10, 2019
    Classification Date
    November 7, 2019
    Termination Date
    May 19, 2020
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012 0202265014

    Reason

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

    Code Info

    All product manufactured prior to January 2014.

    Distribution

    Distributed nationwide.

    Quantity

    5,459,583 total devices