BEUDAMED
    FDA Recall Terminated

    90-5970-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) 10 MM Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

    Recall: Z-1564-2012 · Initiated February 24, 2012

    Recall

    Recall Number
    Z-1564-2012
    Event Number
    61468
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 24, 2012
    Posted
    May 14, 2012
    Terminated
    April 18, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    90-5970-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) 10 MM Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

    Reason

    Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are

    Action

    Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514. For questions regarding this recall call 574-372-4807.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.

    Quantity

    83,322 all sizes