BEUDAMED
    FDA Enforcement Class II Terminated

    PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

    Recall: Z-1224-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1224-2018
    Event ID
    79394
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    December 12, 2017
    Classification Date
    March 27, 2018
    Termination Date
    April 9, 2019
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

    Reason

    A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.

    Code Info

    Item# 42-5320-067-02 Lot # 63236047

    Distribution

    Non-USA Customer

    Quantity

    3 units