BEUDAMED
    FDA Recall 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 · Initiated July 1, 2015

    Recall

    Recall Number
    Z-2201-2015
    Event Number
    71650
    Firm
    Myoscience Inc
    FEI Number
    3009131456
    Product Code
    GXH
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    July 1, 2015
    Posted
    July 22, 2015
    Terminated
    September 8, 2015
    Address
    46400 Fremont Blvd, Fremont, CA, 94538-6469

    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.

    Action

    Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately. Question or concerns may be directed to Customers Service at 510-933-1500.

    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.