BEUDAMED
    FDA Enforcement Class II Terminated

    Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.

    Recall: Z-1937-2012 · Reported July 11, 2012

    Enforcement

    Recall Number
    Z-1937-2012
    Event ID
    61874
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2012
    Initiation Date
    May 4, 2012
    Classification Date
    July 3, 2012
    Termination Date
    August 4, 2016
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767, United States

    Description

    Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.

    Reason

    Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles

    Code Info

    All lots

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.

    Quantity

    683 units