BEUDAMED
    FDA Enforcement Class II Terminated

    PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.

    Recall: Z-0918-2013 · Reported March 13, 2013

    Enforcement

    Recall Number
    Z-0918-2013
    Event ID
    64343
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon Endo-Surgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2013
    Initiation Date
    October 4, 2012
    Classification Date
    March 7, 2013
    Termination Date
    June 11, 2013
    Address
    4545 Creek Rd, N/A, Cincinnati, OH, 45242-2803, United States

    Description

    PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.

    Reason

    Damage to the packaging may have compromised the sterility of the device.

    Code Info

    Expiration dates: September 2012 - August 2017

    Distribution

    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, NICOSIA, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PROVINCE OF CHINA, PUERTO RICO, REPUBLIC OF KOREA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA &, YEMEN.

    Quantity

    5,894,975 pieces