BEUDAMED
    FDA Recall Terminated

    Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS

    Recall: Z-1727-2015 · Initiated May 18, 2015

    Recall

    Recall Number
    Z-1727-2015
    Event Number
    71308
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    LKF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 18, 2015
    Posted
    June 8, 2015
    Terminated
    August 7, 2015
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS

    Reason

    Design of device may expose user to injury to fingers or body parts

    Action

    CooperSurgical initiated the recall on May 18, 2015 via Fedex with confirmed delivery receipt. The letter identified the affected product and asked users to discontinue use and complete the Acknowledgement and Receipt Form to schedule a replacement. Questions contact 203.601.5200.

    Distribution

    Distributed in the states of CA, IL, NC, and NY.

    Quantity

    5 units