BEUDAMED
    FDA Enforcement Class II Terminated

    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease

    Recall: Z-0696-2019 · Reported January 16, 2019

    Enforcement

    Recall Number
    Z-0696-2019
    Event ID
    81773
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon Endo-Surgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 16, 2019
    Initiation Date
    December 7, 2018
    Classification Date
    January 8, 2019
    Termination Date
    April 29, 2020
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803, United States

    Description

    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease

    Reason

    Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired

    Code Info

    Lot Codes: P93K95 P9420Y P94A4T P93L1M P9420Z P94D3N P93M3G P9441H P94F3Z P93T35 P9450L P94G04 P93T7F P9463J P94H5F P93W3M P94765 P94J4W P93W3N P9487Z P94J80 P93Y58 P94901 P94K2A P94117 P94A20 R9200Z

    Distribution

    Worldwide Distribution: US (Nationwide) and to countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, ECUADOR, EGYPT, INDIA, INDONESIA, JAPAN, KOREA, KUWAIT, LEBANON MEXICO, NICARAGUA, PAKISTAN, SAUDI ARABIA, SINGAPORE, TAIWAN URUGUAY and VIETNAM.

    Quantity

    15,264 units