BEUDAMED
    FDA Enforcement Class II Terminated

    Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

    Recall: Z-0730-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0730-2014
    Event ID
    66990
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    November 4, 2013
    Classification Date
    January 13, 2014
    Termination Date
    October 8, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746, United States

    Description

    Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

    Reason

    The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

    Code Info

    Cat No. 00-1113-140-01; lot 75974340

    Distribution

    Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV & WY.

    Quantity

    1,534 units