BEUDAMED
    FDA Recall 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 · Initiated December 7, 2018

    Recall

    Recall Number
    Z-0696-2019
    Event Number
    81773
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 7, 2018
    Terminated
    April 29, 2020
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803

    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

    Action

    The firm, Ethicon, issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to US consignees on 12/7/18, via UPS 2nd day mail. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, LATAM, and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. Letter identifies reason for recall, action to be taken: examine inventory and return recalled product for replacement; complete the Business Reply Form (BRF) confirming receipt of this notice and fax or email it to Stericycle at 1-844-524-3888 or [email protected] within three (3) business days. Please return the BRF even if you do not have the product lots subject to this recall.. Communicate the issue to relevant operating room or materials management personnel, or anyone else in the facility who needs to be informed. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. Customers are required to return all PROXIMATE PPH Hemorrhoidal Circular Stapler products subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by April 1, 2019. Any unused Proximate PPH Hemorrhoidal Circular Stapler product lots subject to this recall returned after April 1, 2019 will not be eligible for replacement. Contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET

    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