BEUDAMED
    FDA Recall 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 · Initiated November 4, 2013

    Recall

    Recall Number
    Z-0730-2014
    Event Number
    66990
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    MBB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 4, 2013
    Posted
    January 13, 2014
    Terminated
    October 8, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    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.

    Action

    Zimmer sent an Urgent Device Removal letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification, idetntify the product and remove from use. If the affected product has been utilized, follow institutional protocol to determine if it is appropriate to place a copy of the notification letter into patient records for the affected product. Complete the attached Response Form and return it via fax to 800-871-7270. Customers were instructed to return a copy of the completed response form along with their returned product to ensure proper credit. Customers with questions were instructed to call 866-608-3941. For questions regarding this recall call 800-613-6131.

    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