BEUDAMED
    FDA Recall 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 · Initiated October 6, 2014

    Recall

    Recall Number
    Z-0877-2015
    Event Number
    69879
    Firm
    PEROUSE MEDICAL ROUTE DU MANOIR Ivry Le Temple France
    FEI Number
    3006942524
    Product Code
    MAV
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 6, 2014
    Posted
    December 29, 2014
    Terminated
    March 24, 2017

    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

    Action

    Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and October 07, 2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements. US distributors have been requested to provide the required information to their customers. In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form.

    Distribution

    US Nationwide Distribution in the states of AZ and CO.

    Quantity

    2184 units