BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0492-2015 · Initiated October 17, 2014

    Recall

    Recall Number
    Z-0492-2015
    Event Number
    69787
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    GAP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 17, 2014
    Posted
    January 9, 2015
    Terminated
    August 14, 2015
    Address
    Highway 22 West, Somerville, NJ, 08876

    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.

    Action

    Ethicon sent an Urgent Medical Device Recall Letter/Business Reply Form dated 10/17/2014 via UPS next day mail.

    Distribution

    Nationwide Distribution

    Quantity

    2,508 each