BEUDAMED
    FDA Enforcement Class II Terminated

    TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.

    Recall: Z-1965-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1965-2016
    Event ID
    74114
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    May 10, 2016
    Classification Date
    June 14, 2016
    Termination Date
    December 16, 2016
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    Description

    TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.

    Reason

    As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges from prior lot numbers manufactured before Integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. The number should be 4, it is 6. 3) The space / holder

    Code Info

    Lot UP15H2, Lot UP09D3, Lot UP07E2

    Distribution

    US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.

    Quantity

    71 units