BEUDAMED
    FDA Enforcement Class II Terminated

    Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

    Recall: Z-0307-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0307-2021
    Event ID
    86590
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2020
    Initiation Date
    September 25, 2020
    Classification Date
    October 29, 2020
    Termination Date
    May 1, 2023
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

    Reason

    The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

    Code Info

    Catalog: 304-21-07; Serial Ranges: 4968615-4968627; 4952421-4952432

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.

    Quantity

    25 devices