BEUDAMED
    FDA Enforcement Class II Terminated

    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.

    Recall: Z-0492-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0492-2015
    Event ID
    69787
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    October 17, 2014
    Classification Date
    December 1, 2014
    Termination Date
    August 14, 2015
    Address
    US Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.

    Reason

    Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

    Code Info

    PERMA-HAND" Silk Suture [Siliconized black braided] Product Code - 10Q06 Lots and Expiration Dates- GPP528 JUL 2018 GPP908 JUL 2018 HAB605 JAN 2019 HAE019 JAN 2019 HAE964 JAN 2019 HAP987 JAN 2019 HBB681 JAN 2019 HBB952 JAN 2019 HBE186 JAN 2019 HCB084 JAN 2019 HCB972 JAN 2019 HCE266 JAN 2019 HCE980 JAN 2019 PERMA-HAND" Silk Suture [Siliconized black braided] Product Code - 10Q07 Lots and Expiration Dates- GPB984 JUL 2018 GPE919 JUL 2018 HAP822 JAN 2019 HBP781 JAN 2019 HCP953 JAN 2019 HCR677 JAN 2019

    Distribution

    Nationwide Distribution

    Quantity

    2,508 each