BEUDAMED
    FDA Enforcement Class II Terminated

    GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.

    Recall: Z-1439-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1439-2013
    Event ID
    65255
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus Acmi, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    May 24, 2013
    Classification Date
    May 31, 2013
    Termination Date
    May 30, 2014
    Address
    136 Turnpike Road, N/A, Southborough, MA, 01772-2118, United States

    Description

    GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.

    Reason

    lack of sterility assurance

    Code Info

    JC477666

    Distribution

    Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.

    Quantity

    100 boxes of 6 units