BEUDAMED
    FDA Enforcement Class II Terminated

    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

    Recall: Z-1841-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1841-2016
    Event ID
    74079
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra York PA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    March 11, 2016
    Classification Date
    May 31, 2016
    Termination Date
    April 17, 2017
    Address
    589 Davies Dr, N/A, York, PA, 17402-8630, United States

    Description

    Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.

    Reason

    One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

    Code Info

    Catalogue No. 4-405, Lot # 97327

    Distribution

    Worldwide distribution. US nationwide, Mexico, and Korea.

    Quantity

    678 Chisel Blade Holders