BEUDAMED
    FDA Enforcement Class II Terminated

    Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.

    Recall: Z-0137-2016 · Reported October 28, 2015

    Enforcement

    Recall Number
    Z-0137-2016
    Event ID
    72366
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Microfixation, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 28, 2015
    Initiation Date
    August 6, 2015
    Classification Date
    October 20, 2015
    Termination Date
    October 13, 2017
    Address
    1520 Tradeport Dr, N/A, Jacksonville, FL, 32218-2480, United States

    Description

    Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.

    Reason

    The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

    Code Info

    Lot Code # 101465 Model # 19-5000

    Distribution

    Nationwide Distribution including CA, FL, OK, NY, NC, and IL.

    Quantity

    5 units