BEUDAMED
    FDA Enforcement Class II Terminated

    Exactech Optetrak Logic CC 15mm Tibial Augment Screws

    Recall: Z-2704-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2704-2017
    Event ID
    77514
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 19, 2017
    Initiation Date
    April 7, 2017
    Classification Date
    July 8, 2017
    Termination Date
    August 4, 2020
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630, United States

    Description

    Exactech Optetrak Logic CC 15mm Tibial Augment Screws

    Reason

    Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.

    Code Info

    Catalog No. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.

    Distribution

    CA and NY.

    Quantity

    9 devices