BEUDAMED
    FDA Enforcement Class II Terminated

    iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue

    Recall: Z-2201-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2201-2015
    Event ID
    71650
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Myoscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    July 1, 2015
    Classification Date
    July 22, 2015
    Termination Date
    September 8, 2015
    Address
    46400 Fremont Blvd, N/A, Fremont, CA, 94538-6469, United States

    Description

    iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue

    Reason

    The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.

    Code Info

    Catalog numbers:STT0412-¿10 and STT0412-¿5; Lot numbers : 1504021-¿01 and 1505008.

    Distribution

    US Nationwide Distribution in the states of TX, NY, MD, CO and CA.

    Quantity

    12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.