BEUDAMED
    FDA Recall Terminated

    Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

    Recall: Z-0008-04 · Initiated September 18, 2003

    Recall

    Recall Number
    Z-0008-04
    Event Number
    27177
    Firm
    Rultract Inc
    FEI Number
    3000717741
    Product Code
    DWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 18, 2003
    Posted
    October 15, 2003
    Terminated
    March 23, 2007
    Address
    5663 Brecksville Rd, Independence, OH, 44131

    Description

    Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

    Reason

    Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.

    Action

    The firm notified their affected consignees by letter on 9/18/2003.

    Distribution

    The device was distributed to end-users located nationwide.

    Quantity

    2,718 units