BEUDAMED
    FDA Recall Terminated

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    Recall: Z-0994-2014 · Initiated December 5, 2013

    Recall

    Recall Number
    Z-0994-2014
    Event Number
    67406
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    December 5, 2013
    Posted
    February 20, 2014
    Terminated
    January 26, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    Reason

    The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.

    Action

    Integra sent an Urgent: Medical Device Correction Letter/Acknowledgement Return Form dated December 5, 2013 via traceable courier to their customers. The notification: advises customers of the nature of the issue and how it could affect CEM Nosecone use, advises customers what to do if the issue occurs and requests customers complete and return the Acknowledgment Return Form. The form should be faxed to [email protected] or 1-609-275-9445. Any questions can be directed to customer service at 855-532-1723.

    Distribution

    Worldwide Distribution - USA Nationwide

    Quantity

    17253 boxes