BEUDAMED
    FDA Enforcement Class II Terminated

    PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

    Recall: Z-1225-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1225-2022
    Event ID
    90140
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 8, 2022
    Initiation Date
    May 4, 2022
    Classification Date
    June 2, 2022
    Termination Date
    January 16, 2024
    Address
    5677 Airline Rd, N/A, Arlington, TN, 38002-9501, United States

    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.

    Code Info

    Catalog Number(s): PHAPCLS7; Lot Number(s): 1903727; Expiration Date: 11/24/2029; UDI/DI Number: 00192629112773

    Distribution

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

    Quantity

    8 units