BEUDAMED
    FDA Enforcement Class II Terminated

    Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO

    Recall: Z-1753-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1753-2015
    Event ID
    71238
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gyrus Acmi, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    May 8, 2015
    Classification Date
    June 11, 2015
    Termination Date
    May 17, 2016
    Address
    136 Turnpike Road, N/A, Southborough, MA, 01772-2118, United States

    Description

    Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO

    Reason

    Potential lack of sterility assurance.

    Code Info

    Lot Number: JC24165

    Distribution

    Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

    Quantity

    22,250 boxes