BEUDAMED
    FDA Recall 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 · Initiated September 25, 2020

    Recall

    Recall Number
    Z-0307-2021
    Event Number
    86590
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    PHX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 25, 2020
    Terminated
    May 1, 2023
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    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.

    Action

    The recalling firm distributed a recall notice to US consignees with affected inventory on 09/25/2020. The recall notice was translated and provided to OUS consignees on 10/082020. Consignees have been instructed to: -Immediately cease distribution or use of this product -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the Recall Inventory Response Form to Exactech.

    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