BEUDAMED
    FDA Enforcement Class II Terminated

    Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.

    Recall: Z-1676-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1676-2013
    Event ID
    65290
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 17, 2013
    Initiation Date
    June 11, 2013
    Classification Date
    July 10, 2013
    Termination Date
    January 30, 2014
    Address
    345 E Main St, N/A, Warsaw, IN, 46580-2746, United States

    Description

    Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.

    Reason

    The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.

    Code Info

    Item 00-4301-012-17; lot 62283991

    Distribution

    Nationwide Distribution including IL and MO.

    Quantity

    1