BEUDAMED
    FDA Recall Terminated

    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.

    Recall: Z-1246-2015 · Initiated February 11, 2015

    Recall

    Recall Number
    Z-1246-2015
    Event Number
    70507
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    MBB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 11, 2015
    Posted
    March 5, 2015
    Terminated
    May 19, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.

    Reason

    One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.

    Action

    DePuy Orthopaedics, Inc. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). Consignees were instructed to discontinue use of the affected lot of bone cement immediately and destroy according to the consignees hazardous materials protocol or return if Certified Dangerous Goods Shipper, holding an International Air Transport Association (IATA) certification. Customers were instructed to call 574-371-4917 (M-F; 8 am 5 pm EST). For questions regarding this recall call 574-371-4577.

    Distribution

    Nationwide Distribution including CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MS, MT, NC, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WV.

    Quantity

    1267