BEUDAMED
    FDA Recall Terminated

    PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

    Recall: Z-1225-2022 · Initiated May 4, 2022

    Recall

    Recall Number
    Z-1225-2022
    Event Number
    90140
    Firm
    MicroPort Orthopedics Inc.
    FEI Number
    3010536692
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    May 4, 2022
    Terminated
    January 16, 2024
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

    Reason

    One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.

    Action

    The firm sent out a recall notification to the distributors on 05/04/2022 via email. Phone calls were also made to the distributors. Additionally, the US field communication letter was mailed to the surgeon and facility in regard to the one case of implantation on May 10, 2022. The consignee letter informed the consignee to cease use and distribution of the affected product, check inventory for affected product, complete the response form, return affected product and notify affected consignees. The field surgeon letter and hospital letter informs the consignee to cease use and distribution of the affected product, monitor patients per normal protocol, return affected product and sign and return the response form.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.

    Quantity

    8 units