BEUDAMED
    FDA Recall Open, Classified

    PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870

    Recall: Z-2486-2020 · Initiated June 10, 2020

    Recall

    Recall Number
    Z-2486-2020
    Event Number
    85820
    Firm
    Ethicon, Inc. Us
    FEI Number
    2210968
    Product Code
    GAP
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 10, 2020
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870

    Reason

    Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years

    Action

    There is no US impact. The firm began notification of customers on June 10, 2020 via URGENT FIELD SAFETY NOTIFICATION letters. Customers were informed that the shelf life of the product is being reduced from 5 years to 3 years (36 months). Any 8-0 Blue Twisted Silk Suture product received prior to June 2019 labeled with an expiration date of 2024-06-20 or earlier is affected by this Field Safety Notification. Customers were asked to acknowledge the notification by completing and returning the business reply form included with the mailing. If you have additional questions regarding this Field Safety Notification or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET. ***Updated 6/29/20*** On 6/12/2020, the recalling firm updated the field action from "Notification" to "Removal". All affected devices are now required to be returned.

    Distribution

    No domestic distribution. Foreign distribution to Algeria Angola Australia Austria Azerbaijan Bahrain Belgium Bosnia and Herzegovina Canada Chad Chile Czechia Egypt Finland France Gabon Germany Greece Hong Kong Iceland India Iran Ireland Israel Italy Japan Jordan Kenya Kuwait Latvia Lebanon Libya Lithuania Mauritius Morocco Mozambique Netherlands (the) New Caledonia New Zealand Nigeria Oman Philippines Poland Portugal Qatar Republic of North Macedonia Russian Federation (the) Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates (the) United Kingdom of Great Britain and Northern Ireland (the)

    Quantity

    99,612 eaches