BEUDAMED
    FDA Enforcement Class II Terminated

    FMsealer Open Shears. Model FM3001

    Recall: Z-0690-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0690-2017
    Event ID
    75627
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Domain Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2016
    Initiation Date
    October 24, 2016
    Classification Date
    December 1, 2016
    Termination Date
    April 11, 2017
    Address
    1370 S 2100 E, Salt Lake City, UT, 84108-2244, United States

    Description

    FMsealer Open Shears. Model FM3001

    Reason

    Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.

    Code Info

    Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091

    Distribution

    Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.

    Quantity

    70 units US; 175 units OUS