BEUDAMED
    FDA Enforcement Class II Terminated

    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

    Recall: Z-0693-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0693-2022
    Event ID
    89471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ROi CPS LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 9, 2022
    Initiation Date
    January 13, 2022
    Classification Date
    February 28, 2022
    Termination Date
    September 28, 2022
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758, United States

    Description

    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

    Reason

    Products are mislabeled with the incorrect product identification on individual kit labeling.

    Code Info

    Item No. 8800297010; Lot No. 90328; UDI 10194717113164

    Distribution

    Missouri

    Quantity

    50 kits