BEUDAMED
    FDA Recall 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 · Initiated May 8, 2015

    Recall

    Recall Number
    Z-1753-2015
    Event Number
    71238
    Firm
    Gyrus Acmi, Incorporated
    FEI Number
    3003790304
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 8, 2015
    Posted
    June 11, 2015
    Terminated
    May 17, 2016
    Address
    136 Turnpike Road, Southborough, MA, 01772-2118

    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.

    Action

    The firm notified their direct accounts of the recall by Fed Ex Second Day on 05/08/2015. The letter requesting disposal of the product was extended to hospitals or medical practices that purchased the product. Non-responding consignees will be contacted again if necessary.

    Distribution

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

    Quantity

    22,250 boxes