BEUDAMED
    FDA Enforcement Class II Terminated

    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.

    Recall: Z-1522-2014 · Reported May 7, 2014

    Enforcement

    Recall Number
    Z-1522-2014
    Event ID
    67902
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2014
    Initiation Date
    March 10, 2014
    Classification Date
    April 29, 2014
    Termination Date
    February 13, 2015
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    Description

    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.

    Reason

    Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.

    Code Info

    Product/Catalog Number C5601; Lot Numbers 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873 and 1135014

    Distribution

    Worldwide Distribution - USA (nationwide) including the countries of Australia, Canada, and Switzerland.

    Quantity

    3,984 devices packaged as 6 devices / box (664 boxes)