BEUDAMED
    FDA Enforcement Class II Terminated

    Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

    Recall: Z-0752-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0752-2017
    Event ID
    75710
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra York PA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    October 28, 2016
    Classification Date
    December 13, 2016
    Termination Date
    April 17, 2017
    Address
    589 Davies Dr, York, PA, 17402-8630, United States

    Description

    Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.

    Reason

    The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.

    Code Info

    Catalog # ST5-182; lot# 355

    Distribution

    US Distribution in NC and TX.

    Quantity

    50 units