BEUDAMED
    FDA Enforcement Class II Terminated

    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.

    Recall: Z-2385-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2385-2012
    Event ID
    62899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tedan Surgical Innovations Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    June 11, 2012
    Classification Date
    September 14, 2012
    Termination Date
    July 31, 2013
    Address
    12615 W Airport Blvd, Ste 200, Sugar Land, TX, 77478-6203, United States

    Description

    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.

    Reason

    This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.

    Code Info

    Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782, 021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.

    Quantity

    12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution