BEUDAMED
    FDA Recall Terminated

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    Recall: Z-0960-2013 · Initiated January 15, 2013

    Recall

    Recall Number
    Z-0960-2013
    Event Number
    64072
    Firm
    DePuy Spine, Inc.
    FEI Number
    1526439
    Product Code
    NDN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 15, 2013
    Posted
    March 18, 2013
    Terminated
    June 30, 2014
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    Description

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. 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

    Action

    DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the enclosed Business Reply Form. Contact the firm at 508-977-6606 for questions relating to this notice.

    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

    1023