BEUDAMED
    FDA Enforcement Class II Terminated

    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

    Recall: Z-0021-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0021-2015
    Event ID
    69280
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 15, 2014
    Initiation Date
    September 17, 2014
    Classification Date
    October 6, 2014
    Termination Date
    July 14, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46581, United States

    Description

    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

    Reason

    Investigation determined that units supplied were missing the 4x21 degree helix angle.

    Code Info

    Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290

    Distribution

    International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.

    Quantity

    4