BEUDAMED
    FDA Enforcement Class II Terminated

    cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001

    Recall: Z-0338-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0338-2020
    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

    cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001

    Reason

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

    Code Info

    12752657 12784266 12784266 12784266 12778187 12778187 12752661 12784267 12784267 12784267 12776194 12784268 12784268 12784268 12774326 12753709 12753702 12753707 12784261

    Distribution

    Distributed nationwide.

    Quantity

    5459583 total devices