BEUDAMED
    FDA Enforcement Class II Terminated

    INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.

    Recall: Z-2684-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2684-2016
    Event ID
    74867
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2016
    Initiation Date
    August 4, 2016
    Classification Date
    August 29, 2016
    Termination Date
    December 19, 2016
    Address
    3498 W 2400 S Ste 1050, N/A, Salt Lake City, UT, 84119-1135, United States

    Description

    INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.

    Reason

    Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.

    Code Info

    The affected lots of Integra¿ Spinal Trays were manufactured on 2/11/205 and on 7/11/2015. Lots: W1503004; S1501531; S1505556;

    Distribution

    US Distribution to the states of : OH and CA. No foreign, Govt/VA/military consignee.

    Quantity

    200 packages (20 cases)