BEUDAMED
    FDA Recall Terminated

    Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.

    Recall: Z-1247-2016 · Initiated February 26, 2013

    Recall

    Recall Number
    Z-1247-2016
    Event Number
    73407
    Firm
    Neurotherm, Inc.
    FEI Number
    3002953813
    Product Code
    GXI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 26, 2013
    Posted
    March 24, 2016
    Terminated
    March 25, 2016
    Address
    600 Research Dr, Ste 1, Wilmington, MA, 01887-4438

    Description

    Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.

    Reason

    Straight needle labeled as a curved needle

    Action

    NeuroTherm notified consignees by telephone between February 2- March 15, 2013 about the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return devices.

    Distribution

    US Nationwide Distribution in the states of CA ,CO, OH, OR

    Quantity

    135 cannulas (27 boxes/5)