BEUDAMED
    FDA Enforcement Class II Terminated

    T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.

    Recall: Z-1932-2013 · Reported August 14, 2013

    Enforcement

    Recall Number
    Z-1932-2013
    Event ID
    64993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2013
    Initiation Date
    August 29, 2012
    Classification Date
    August 8, 2013
    Termination Date
    October 18, 2013
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.

    Reason

    During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.

    Code Info

    Lot Numbers: 1335201A, 1446101A

    Distribution

    US Distribution including the states of MA, NV and TX.

    Quantity

    11