BEUDAMED
    FDA Recall Terminated

    Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

    Recall: Z-1866-2016 · Initiated March 7, 2016

    Recall

    Recall Number
    Z-1866-2016
    Event Number
    73684
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 7, 2016
    Posted
    May 31, 2016
    Terminated
    March 31, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

    Reason

    Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

    Action

    Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service.

    Distribution

    AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

    Quantity

    30,146 Instruments