BEUDAMED
    FDA Enforcement Class II Terminated

    NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313

    Recall: Z-0303-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0303-2020
    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 Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313

    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