BEUDAMED
    FDA Recall Terminated

    FMsealer Open Shears. Model FM3001

    Recall: Z-0690-2017 · Initiated October 24, 2016

    Recall

    Recall Number
    Z-0690-2017
    Event Number
    75627
    Firm
    Domain Surgical, Inc.
    FEI Number
    3005350457
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 24, 2016
    Posted
    December 1, 2016
    Terminated
    April 11, 2017
    Address
    1370 S 2100 E, Salt Lake City, UT, 84108-2244

    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.

    Action

    Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc.

    Distribution

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

    Quantity

    70 units US; 175 units OUS