BEUDAMED
    FDA Enforcement Class II Terminated

    Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

    Recall: Z-2086-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2086-2013
    Event ID
    65672
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alphatec Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 4, 2013
    Initiation Date
    June 28, 2013
    Classification Date
    August 27, 2013
    Termination Date
    October 9, 2014
    Address
    5818 El Camino Real, Carlsbad, CA, 92008-8816, United States

    Description

    Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

    Reason

    The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver.

    Code Info

    Part Number 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.

    Distribution

    Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan. International: Spain, France, Japan.

    Quantity

    333 screws