BEUDAMED
    FDA Enforcement Class II Terminated

    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).

    Recall: Z-2107-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2107-2018
    Event ID
    80095
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroAire Surgical Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    April 19, 2018
    Classification Date
    June 7, 2018
    Termination Date
    April 10, 2020
    Address
    3590 Grand Forks Blvd, N/A, Charlottesville, VA, 22911-9006, United States

    Description

    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).

    Reason

    The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.

    Code Info

    All products distributed from 1/1/13 to 2/23/18

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of: Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.

    Quantity

    2009