BEUDAMED
    FDA Recall Terminated

    Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876

    Recall: Z-0173-2010 · Initiated September 28, 2009

    Recall

    Recall Number
    Z-0173-2010
    Event Number
    53535
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    HET
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 28, 2009
    Posted
    November 10, 2009
    Terminated
    August 2, 2010
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876

    Reason

    There is the potential for the duckbill seal to become dislodged.

    Action

    Recall notification letters titled "URGENT VOLUNTARY PRODUCT RECALL" were sent on 10/8/2009 via UPS next day. The letters describe the lots within expiration that are recalled. The motor drive unit is not included in the recall. Letters have photos and illustrations of the product which clearly show the location of the product code and expiration date. Recalled product is to be returned to Stericyle using an enclosed pre-paid authorized shipping label. Ethicon will notify customers when the product is available. Questions are to be directed to Ethicon at 1-888-276-5901.

    Distribution

    Worldwide distribution - US and United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Greece, Israel, Italy, Jordan, Republic of Korea, Mexico, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, Reunion, Russian Federation, Sweden, Slovina, Turkey, Saudi Arabia, Venezuela and S. Africa.

    Quantity

    60,930 in US.