BEUDAMED
    FDA Enforcement Class II Terminated

    00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain.

    Recall: Z-1998-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1998-2013
    Event ID
    65413
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 28, 2013
    Initiation Date
    June 7, 2013
    Classification Date
    August 22, 2013
    Termination Date
    December 15, 2014
    Address
    345 E Main St, N/A, Warsaw, IN, 46580-2746, United States

    Description

    00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain.

    Reason

    Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper combination labeling, but the mis match problem continues. Zimmer is removing the d

    Code Info

    REF 00597001101, all codes

    Distribution

    Worldwide Distribution-USA (nationwide) and the country of Japan.

    Quantity

    192,355 all devices