BEUDAMED
    FDA Recall Terminated

    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

    Recall: Z-0603-2018 · Initiated July 11, 2017

    Recall

    Recall Number
    Z-0603-2018
    Event Number
    78064
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 11, 2017
    Posted
    January 18, 2018
    Terminated
    April 22, 2021
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

    Reason

    Vix Bit may fracture during use.

    Action

    Customers were notified on approximately 07/11/2017. Instructions included cease distribution of the affected product, notify customers if further distributed, identify and quarantine any product in inventory and complete and return the Recall Inventory Response Form. For further questions, please call (800) 392-2832.

    Distribution

    Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.

    Quantity

    41 devices