BEUDAMED
    FDA Recall Terminated

    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

    Recall: Z-1029-2015 · Initiated December 5, 2014

    Recall

    Recall Number
    Z-1029-2015
    Event Number
    69963
    Firm
    Orthosensor, Inc.
    FEI Number
    3008592715
    Product Code
    ONN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 5, 2014
    Posted
    January 29, 2015
    Terminated
    March 13, 2015
    Address
    1560 Sawgrass Corporate Pkwy, Floor 4th, Sunrise, FL, 33323-2858

    Description

    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

    Reason

    Presence of one inoperable (dead) sensor pad.

    Action

    OrthoSensor sent an Recall letter dated December 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users " Remove the above-referenced serial numbers from your VERASENSE inventory and quarantine. " Complete the enclosed Customer Response Form. Actions to be taken by OrthoSensor " You will be credited for these devices for your full purchase amount. The Returned Materials Authorization (RMA) number for each device in your possession is listed above. " OrthoSensor will replenish these devices as soon as they are available. For further questions please call (954) 577-7770.

    Distribution

    US Distribution to the states of : IL, MI, NY, CA, VA and NV.

    Quantity

    22 devices