BEUDAMED
    FDA Recall Terminated

    CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

    Recall: Z-2134-2013 · Initiated April 17, 2013

    Recall

    Recall Number
    Z-2134-2013
    Event Number
    64937
    Firm
    DePuy Spine, Inc.
    FEI Number
    1526439
    Product Code
    NDN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 17, 2013
    Posted
    September 3, 2013
    Terminated
    August 13, 2014
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    Description

    CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

    Reason

    During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.

    Action

    DePut Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated April 15, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the con signee. Consignees were instructed to review their inventory and quarantine for return any products listed in the recall notice., complete the enclosed Business Reply Form, indicating level of inventory of the affected product and return the form to Depuy via fax to 888-943-4897or email to [email protected] and to return the product with the enclosed UPS label to Stericycle. For questions regarding this recall call 508-977-6606.

    Distribution

    Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY; Worldwide: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE, and UK

    Quantity

    3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)