BEUDAMED
    FDA Enforcement Class II Terminated

    Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

    Recall: Z-0716-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0716-2014
    Event ID
    67142
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    December 19, 2013
    Classification Date
    January 10, 2014
    Termination Date
    July 7, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

    Reason

    3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

    Code Info

    Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D

    Distribution

    US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.

    Quantity

    52