BEUDAMED
    FDA Enforcement Class II Terminated

    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.

    Recall: Z-1247-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1247-2014
    Event ID
    67775
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2014
    Initiation Date
    March 18, 2014
    Classification Date
    March 20, 2014
    Termination Date
    May 15, 2014
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.

    Reason

    Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm  7cm.

    Code Info

    P/N 5290-628-000, Lot #13280CG2

    Distribution

    US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia

    Quantity

    90 units