BEUDAMED
    FDA Enforcement Class II Terminated

    Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.

    Recall: Z-0900-2015 · Reported January 7, 2015

    Enforcement

    Recall Number
    Z-0900-2015
    Event ID
    69904
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 7, 2015
    Initiation Date
    December 8, 2014
    Classification Date
    December 31, 2014
    Termination Date
    July 17, 2015
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.

    Reason

    Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55-0000-310-01.

    Code Info

    PMA #N17755, decision date 5/17/1976, reclassified 10/14/1999. Class II device; D033511, Item No. 00-1101-012-00; lot 62849791, 14D0809, Manufactured between 9/11/2014-10/6/2014; EXP date: 4/30/2017

    Distribution

    Distributed to MI, KS, and CA.

    Quantity

    40 units