BEUDAMED
    FDA Recall Terminated

    Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.

    Recall: Z-0356-2012 · Initiated October 14, 2011

    Recall

    Recall Number
    Z-0356-2012
    Event Number
    60300
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    FCW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 14, 2011
    Posted
    December 2, 2011
    Terminated
    March 8, 2012
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.

    Reason

    A loose screw may result in shifting of components and improper function of the turret or actuator assembly.

    Action

    Integra sent an URGENT: Field Corrective Action letter dated October 14, 2011 to all affected customers via FedEx. The letter identified the affected product, the problem, and the actions to be taken with instructions to immediately inspect their inventory for potentially loose screws within the affected unit(s). If the unit(s) were observed with loose screws, the unit(s) were to be returned to Integra Surgical for repair and servicing. Customers were instructed to complete the Acknowledgement and Return Form per the instructions on the form. For questions call Integra Surgical Customer Service at 1-800-431-1123.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: Arizona, California, Colorado, Florida, Indiana, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Montana, Washington, Wyoming, and Puerto Rico, and the countries of: Australia, Germany, Italy, Japan, Netherlands, New Zealand, Pakistan, Sweden, Switzerland, and Turkey.

    Quantity

    66 units