BEUDAMED
    FDA Recall Terminated

    Exactech Optetrak Logic CC 15mm Tibial Augment Screws

    Recall: Z-2704-2017 · Initiated April 7, 2017

    Recall

    Recall Number
    Z-2704-2017
    Event Number
    77514
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 7, 2017
    Posted
    June 19, 2017
    Terminated
    August 4, 2020
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    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.

    Action

    Consignees were initially contacted by phone on 04/07/2017. Consignees were sent a recall notice by mail, dated 04/13/2017. The notice requested that consignees immediately cease distribution/use of product, that the recall Extend the information to accounts in possession of the product Identify/quarantine any subject devices in your inventory Complete & return the attached Recall Inventory Response Form to Exactech within 5 business days at 2411 NW 66th Ct, Gainesville, FL 32653 or faxed to 352-337-3915. Questions from customers are to be directed to Kaya Davis at [email protected] or 800-392-2832.

    Distribution

    CA and NY.

    Quantity

    9 devices