BEUDAMED
    FDA Recall Terminated

    Optima Spinal System and Spinal Hook System, set screw component.

    Recall: Z-1438-04 · Initiated August 10, 2004

    Recall

    Recall Number
    Z-1438-04
    Event Number
    29872
    Firm
    U & I America
    FEI Number
    3003200830
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2004
    Posted
    September 8, 2004
    Terminated
    November 29, 2005
    Address
    6132 S 380 W, Ste 200, Murray, UT, 84107-6988

    Description

    Optima Spinal System and Spinal Hook System, set screw component.

    Reason

    Threads on a set screw, as a component of a spinal fixation system, may break off during use.

    Action

    Consignee was notified by letter on 08/10/2004.

    Distribution

    CA

    Quantity

    200 set screws