BEUDAMED
    FDA Recall Terminated

    Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.

    Recall: Z-2145-2014 · Initiated July 16, 2014

    Recall

    Recall Number
    Z-2145-2014
    Event Number
    68745
    Firm
    Market-Tiers Inc
    FEI Number
    1000219003
    Product Code
    HET
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 16, 2014
    Posted
    August 2, 2014
    Terminated
    May 11, 2015
    Address
    8097 Flint St, Lenexa, KS, 66214-3335

    Description

    Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.

    Reason

    Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.

    Action

    The recalling firm issued a letter dated 7/16/14 via Federal Express requesting the customer destroy the incorrect IFU and replace it with the corrected version.

    Distribution

    Nationwide Distribution.

    Quantity

    100 units