BEUDAMED
    FDA Recall Terminated

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247

    Recall: Z-0831-2015 · Initiated November 7, 2014

    Recall

    Recall Number
    Z-0831-2015
    Event Number
    69803
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 7, 2014
    Posted
    December 18, 2014
    Terminated
    August 11, 2015
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247

    Reason

    Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.

    Action

    Integra sent Urgent- Voluntary Medical Device Recall Letters/Recall Acknowledgement and Return Form dated 11/7/2014 to customers and distributors via traceable courier service.

    Distribution

    Nationwide, Foreign

    Quantity

    2,506 units