BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

    Recall: Z-0877-2015 · Reported January 7, 2015

    Enforcement

    Recall Number
    Z-0877-2015
    Event ID
    69879
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PEROUSE MEDICAL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 7, 2015
    Initiation Date
    October 6, 2014
    Classification Date
    December 29, 2014
    Termination Date
    March 24, 2017
    Address
    ROUTE DU MANOIR, N/A, Ivry Le Temple, N/A, N/A, France

    Description

    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

    Reason

    Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

    Code Info

    Batch numbers: 4041354/4062650/4072586

    Distribution

    US Nationwide Distribution in the states of AZ and CO.

    Quantity

    2184 units