BEUDAMED
    FDA Enforcement Class II Terminated

    PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412

    Recall: Z-0313-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0313-2020
    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

    PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412

    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