BEUDAMED
    FDA Enforcement Class II Terminated

    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

    Recall: Z-1326-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1326-2016
    Event ID
    73561
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    February 23, 2016
    Classification Date
    April 5, 2016
    Termination Date
    September 8, 2016
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

    Reason

    Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.

    Code Info

    Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833, Lot numbers: 9960359, 9962300, 9967875

    Distribution

    Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of Canada and Switzerland.

    Quantity

    500 units distributed in USA, and 35 units distributed OUS