BEUDAMED
    FDA Enforcement Class II Terminated

    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch

    Recall: Z-0789-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0789-2013
    Event ID
    63823
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Linvatec Corp. dba ConMed Linvatec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    November 15, 2012
    Classification Date
    February 5, 2013
    Termination Date
    May 22, 2013
    Address
    11311 Concept Blvd, N/A, Largo, FL, 33773-4908, United States

    Description

    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch

    Reason

    ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.

    Code Info

    Lot 256058

    Distribution

    Worldwide Distribution - USA including California and Internationally to Spain and Korea

    Quantity

    8