BEUDAMED
    FDA Recall Terminated

    Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel

    Recall: Z-1201-2017 · Initiated August 20, 2014

    Recall

    Recall Number
    Z-1201-2017
    Event Number
    76344
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    3000204839
    Product Code
    MWS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 20, 2014
    Posted
    February 14, 2017
    Terminated
    February 15, 2017
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    Description

    Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.

    Action

    Terumo Cardiovascular Systems has contact all affected parties (user facilities and consignees) via a Customer Notification Letter that advises of the recall activity.

    Distribution

    Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .

    Quantity

    The total number of distributed devices stands at 260