BEUDAMED
    FDA Enforcement Class II Terminated

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    Recall: Z-0962-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0962-2013
    Event ID
    64072
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    January 15, 2013
    Classification Date
    March 18, 2013
    Termination Date
    June 30, 2014
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    Reason

    Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

    Code Info

    All lots

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.

    Quantity

    7773